4 Medical Device Manufacturing jobs in Pakistan
QC Manager - Medical Device Manufacturing
Sindh, Sindh
Kamion Pharma
Posted 13 days ago
Job Viewed
Job Description
QC Manager - Medical Device Manufacturing
Location: SITE, Super Highway, Phase-II, Karachi
Position Overview:
The Quality Control (QC) Manager will be responsible for overseeing quality control activities in a medical device manufacturing facility, ensuring products meet high standards, regulatory requirements, customer expectations, and QMS compliance. This role includes managing a team, coordinating testing, improving quality processes, and supporting other departments like Quality Assurance and technical problem resolution. The QC Manager is also responsible for using and maintaining inspection methods and equipment to ensure timely and compliant results.
Key Responsibilities:
- Supervise and support QC inspectors and technicians to ensure adherence to company standards and prevent delays or product unavailability.
- Develop and implement quality control procedures to ensure compliance with ISO 13485 and DRAP regulations, demonstrating technical proficiency in analytical methodology and adherence to GMP and ICH standards.
- Ensure the timely disposition of raw materials, packaging materials, and finished products based on priorities set with Manufacturing, Marketing, and Materials Management, while overseeing inspection and testing to meet quality and efficiency standards.
- Review the daily QC Lab planning schedule. Monitor adherence to quality standards, regulations, and best practices. Perform regular audits of QC processes.
- Ensure the implementation of the product stability testing & evaluation as per SOP to verify shelf-life compliance and identify quality issues related to product stability.
- Gather and analyze quality data, generate reports, and suggest actions for quality improvement.
- Investigate quality issues or non-conformities and collaborate with other departments to resolve them.
- Oversee Quality Risk Management and Change Controls within the QC and Micro Lab domains, identifying areas for improvement and implementing changes to enhance product quality and manufacturing processes.
- Ensure all vendors are qualified and comply with vendor standards, collaborating with suppliers to maintain material quality and conducting evaluations and audits as necessary.
- Assist in preparing for and participating in external audits and inspections, providing required documentation and evidence of compliance.
- Maintain accurate records of quality control activities, including inspection and testing reports.
Required Skills and Qualifications:
- Must have a pharmacy, biomedical engineering, or biotechnology degree recognized by HEC.
- A minimum of 5-6 years of experience in quality control and testing, preferably within a medical device manufacturing environment, with at least 4 years in a supervisory position.
- Certification in quality control or quality management systems (e.g., CQE, CQA) is preferred.
- In-depth knowledge of ISO 13485, DRAP regulations, and other relevant standards for medical device manufacturing.
- Exceptional leadership and team management skills, strong analytical and problem-solving abilities, meticulous attention to detail, and effective communication skills required.
This position offers a unique opportunity to work in a dynamic and challenging environment where you can apply your skills and experience to drive improvements and ensure the success of the Quality Control Department.
Application Process:
Please submit your CV/Resume detailing your experience and qualifications with the subject line ‘QC Manager’.
#J-18808-Ljbffr
This advertiser has chosen not to accept applicants from your region.
0
QC Manager - Medical Device Manufacturing
Karachi, Sindh
Kamion Pharma
Posted 10 days ago
Job Viewed
Job Description
QC Manager - Medical Device Manufacturing
Location:
SITE, Super Highway, Phase-II, Karachi Position Overview: The Quality Control (QC) Manager will be responsible for overseeing quality control activities in a medical device manufacturing facility, ensuring products meet high standards, regulatory requirements, customer expectations, and QMS compliance. This role includes managing a team, coordinating testing, improving quality processes, and supporting other departments like Quality Assurance and technical problem resolution. The QC Manager is also responsible for using and maintaining inspection methods and equipment to ensure timely and compliant results. Key Responsibilities: Supervise and support QC inspectors and technicians to ensure adherence to company standards and prevent delays or product unavailability. Develop and implement quality control procedures to ensure compliance with ISO 13485 and DRAP regulations, demonstrating technical proficiency in analytical methodology and adherence to GMP and ICH standards. Ensure the timely disposition of raw materials, packaging materials, and finished products based on priorities set with Manufacturing, Marketing, and Materials Management, while overseeing inspection and testing to meet quality and efficiency standards. Review the daily QC Lab planning schedule. Monitor adherence to quality standards, regulations, and best practices. Perform regular audits of QC processes. Ensure the implementation of the product stability testing & evaluation as per SOP to verify shelf-life compliance and identify quality issues related to product stability. Gather and analyze quality data, generate reports, and suggest actions for quality improvement. Investigate quality issues or non-conformities and collaborate with other departments to resolve them. Oversee Quality Risk Management and Change Controls within the QC and Micro Lab domains, identifying areas for improvement and implementing changes to enhance product quality and manufacturing processes. Ensure all vendors are qualified and comply with vendor standards, collaborating with suppliers to maintain material quality and conducting evaluations and audits as necessary. Assist in preparing for and participating in external audits and inspections, providing required documentation and evidence of compliance. Maintain accurate records of quality control activities, including inspection and testing reports. Required Skills and Qualifications: Must have a pharmacy, biomedical engineering, or biotechnology degree recognized by HEC. A minimum of 5-6 years of experience in quality control and testing, preferably within a medical device manufacturing environment, with at least 4 years in a supervisory position. Certification in quality control or quality management systems (e.g., CQE, CQA) is preferred. In-depth knowledge of ISO 13485, DRAP regulations, and other relevant standards for medical device manufacturing. Exceptional leadership and team management skills, strong analytical and problem-solving abilities, meticulous attention to detail, and effective communication skills required. This position offers a unique opportunity to work in a dynamic and challenging environment where you can apply your skills and experience to drive improvements and ensure the success of the Quality Control Department. Application Process: Please submit your CV/Resume detailing your experience and qualifications with the subject line ‘QC Manager’.
#J-18808-Ljbffr
Location:
SITE, Super Highway, Phase-II, Karachi Position Overview: The Quality Control (QC) Manager will be responsible for overseeing quality control activities in a medical device manufacturing facility, ensuring products meet high standards, regulatory requirements, customer expectations, and QMS compliance. This role includes managing a team, coordinating testing, improving quality processes, and supporting other departments like Quality Assurance and technical problem resolution. The QC Manager is also responsible for using and maintaining inspection methods and equipment to ensure timely and compliant results. Key Responsibilities: Supervise and support QC inspectors and technicians to ensure adherence to company standards and prevent delays or product unavailability. Develop and implement quality control procedures to ensure compliance with ISO 13485 and DRAP regulations, demonstrating technical proficiency in analytical methodology and adherence to GMP and ICH standards. Ensure the timely disposition of raw materials, packaging materials, and finished products based on priorities set with Manufacturing, Marketing, and Materials Management, while overseeing inspection and testing to meet quality and efficiency standards. Review the daily QC Lab planning schedule. Monitor adherence to quality standards, regulations, and best practices. Perform regular audits of QC processes. Ensure the implementation of the product stability testing & evaluation as per SOP to verify shelf-life compliance and identify quality issues related to product stability. Gather and analyze quality data, generate reports, and suggest actions for quality improvement. Investigate quality issues or non-conformities and collaborate with other departments to resolve them. Oversee Quality Risk Management and Change Controls within the QC and Micro Lab domains, identifying areas for improvement and implementing changes to enhance product quality and manufacturing processes. Ensure all vendors are qualified and comply with vendor standards, collaborating with suppliers to maintain material quality and conducting evaluations and audits as necessary. Assist in preparing for and participating in external audits and inspections, providing required documentation and evidence of compliance. Maintain accurate records of quality control activities, including inspection and testing reports. Required Skills and Qualifications: Must have a pharmacy, biomedical engineering, or biotechnology degree recognized by HEC. A minimum of 5-6 years of experience in quality control and testing, preferably within a medical device manufacturing environment, with at least 4 years in a supervisory position. Certification in quality control or quality management systems (e.g., CQE, CQA) is preferred. In-depth knowledge of ISO 13485, DRAP regulations, and other relevant standards for medical device manufacturing. Exceptional leadership and team management skills, strong analytical and problem-solving abilities, meticulous attention to detail, and effective communication skills required. This position offers a unique opportunity to work in a dynamic and challenging environment where you can apply your skills and experience to drive improvements and ensure the success of the Quality Control Department. Application Process: Please submit your CV/Resume detailing your experience and qualifications with the subject line ‘QC Manager’.
#J-18808-Ljbffr
This advertiser has chosen not to accept applicants from your region.
1
Senior Full Stack Developer / Architect For Software As A Medical Device
Islamabad, Islamabad
Cerebral Innovations
Posted 13 days ago
Job Viewed
Job Description
Senior Full Stack Developer / Architect For Software As A Medical Device
Opening Statement: This is a unique and challenging position. We are seeking a lead programmer obsessed with product and company success. We are offering competitive starting pay with the opportunity for major incentives/raises/bonuses. Expectations are high and the selected candidate will be responsible for leading the programming department and learning/applying new skills specific to this position. This position will inherently require that the applicant be adaptable. A thorough understanding of systems and Software Development Lifecycle (SDLC) is required.
The core product is programmed in SWIFT and runs on an iPad Pro 11-inch tablet using the Apple Pencil 2 Stylus.
Our backend uses a combination of the following: EC2 instances with Django, Gunicorn, and Nginx; AWS cloud, Amazon RDS (PostgreSQL), S3 and Amazon CloudFront, and Heroku. Please note that some of these components might have changed in the newest release and the new team is able to restructure them.
We also utilize an admin panel website and various API/SDK’s from 3rd party apps and unrestricted open-source code.
Job SpecificationKey Responsibilities:
- Transition and Transform Current Software Prototype: Lead transition process from old software team to you and your team. Assist in creation of a small team of 2-3 core programmers.
- Manage SDLC: Drive all stages of the Software Development Life Cycle (SDLC), ensuring our medical device software aligns with FDA guidelines & IEC 62304 from prototype to deployment and maintenance.
- Architecture & Programming: Pragmatically develop and improve software architecture by weighing pros and cons with options (e.g., determine when we should program aspects ourselves vs. using open source, API, out of the box solutions, etc.).
- Team Management: Lead our programming team and communicate with CEO when additional people are required full time or for specific contracted roles (e.g., we might hire a cybersecurity expert for 1 month of work).
- Regulatory Learning: It is likely that the applicant will not have experience in all required regulatory areas. As such, it will be mandatory for candidate to learn these regulations alongside the CEO and regulatory expert on the team. The selected candidate will need to comprehend regulations and ensure all clauses are systematically designed, implemented, and verified.
- Risk Management: Implement an effective risk management process that identifies and mitigates potential hazards throughout the software's lifecycle, in alignment with ISO 14971 standards.
- Quality Management: Establish a robust Quality Management System (QMS) per FDA's Quality System Regulation (QSR) and ISO 13485.
- Validation and Verification (V&V) Leadership: Direct and perform V&V activities ensuring that the software/device meet user needs, intended uses, and consistently fulfills all requirements.
- Design Control Procedures: Implement design controls in compliance with FDA regulations (21 CFR 820.30).
- Cybersecurity Governance: Address potential vulnerabilities, strategize, and oversee cybersecurity in compliance with FDA guidelines.
- Data Integrity and Security: Ensure robust data integrity, security, and compliance with laws like HIPAA and GDPR.
Qualifications:
- Full stack programming background required.
- Clear experience and success in senior programming roles required.
- Prior experience in medical software and/or devices is recommended, but not required.
- Familiarity with regulatory standards (CFR 820, CFR 21 part 11, IEC 62304, ISO 13485, and relevant security guidelines) is beneficial, but the ability to learn and apply these regulations is also acceptable as guidance will be provided.
- High intelligence required. A steep learning curve will be necessary to learn various regulations.
Job Type: Full-time
Application Question(s):
- Please describe your greatest accomplishment.
- Please provide any metrics that would be useful in understanding your credentials. For example, metrics that describe your academic experience, intelligence, test scores, team sizes you've worked with, etc.
Location: Biotechnology - Nowshera Cantonment, Pakistan
#J-18808-Ljbffr
This advertiser has chosen not to accept applicants from your region.
2
Senior Full Stack Developer / Architect For Software As A Medical Device
Islamabad, Islamabad
Cerebral Innovations
Posted 25 days ago
Job Viewed
Job Description
Senior Full Stack Developer / Architect For Software As A Medical Device
Opening Statement:
This is a unique and challenging position. We are seeking a lead programmer obsessed with product and company success. We are offering competitive starting pay with the opportunity for major incentives/raises/bonuses. Expectations are high and the selected candidate will be responsible for leading the programming department and learning/applying new skills specific to this position. This position will inherently require that the applicant be adaptable. A thorough understanding of systems and Software Development Lifecycle (SDLC) is required. The core product is programmed in SWIFT and runs on an iPad Pro 11-inch tablet using the Apple Pencil 2 Stylus. Our backend uses a combination of the following: EC2 instances with Django, Gunicorn, and Nginx; AWS cloud, Amazon RDS (PostgreSQL), S3 and Amazon CloudFront, and Heroku. Please note that some of these components might have changed in the newest release and the new team is able to restructure them. We also utilize an admin panel website and various API/SDK’s from 3rd party apps and unrestricted open-source code. Job Specification
Key Responsibilities: Transition and Transform Current Software Prototype: Lead transition process from old software team to you and your team. Assist in creation of a small team of 2-3 core programmers. Manage SDLC: Drive all stages of the Software Development Life Cycle (SDLC), ensuring our medical device software aligns with FDA guidelines & IEC 62304 from prototype to deployment and maintenance. Architecture & Programming: Pragmatically develop and improve software architecture by weighing pros and cons with options (e.g., determine when we should program aspects ourselves vs. using open source, API, out of the box solutions, etc.). Team Management: Lead our programming team and communicate with CEO when additional people are required full time or for specific contracted roles (e.g., we might hire a cybersecurity expert for 1 month of work). Regulatory Learning: It is likely that the applicant will not have experience in all required regulatory areas. As such, it will be mandatory for candidate to learn these regulations alongside the CEO and regulatory expert on the team. The selected candidate will need to comprehend regulations and ensure all clauses are systematically designed, implemented, and verified. Risk Management: Implement an effective risk management process that identifies and mitigates potential hazards throughout the software's lifecycle, in alignment with ISO 14971 standards. Quality Management: Establish a robust Quality Management System (QMS) per FDA's Quality System Regulation (QSR) and ISO 13485. Validation and Verification (V&V) Leadership: Direct and perform V&V activities ensuring that the software/device meet user needs, intended uses, and consistently fulfills all requirements. Design Control Procedures: Implement design controls in compliance with FDA regulations (21 CFR 820.30). Cybersecurity Governance: Address potential vulnerabilities, strategize, and oversee cybersecurity in compliance with FDA guidelines. Data Integrity and Security: Ensure robust data integrity, security, and compliance with laws like HIPAA and GDPR. Qualifications: Full stack programming background required. Clear experience and success in senior programming roles required. Prior experience in medical software and/or devices is recommended, but not required. Familiarity with regulatory standards (CFR 820, CFR 21 part 11, IEC 62304, ISO 13485, and relevant security guidelines) is beneficial, but the ability to learn and apply these regulations is also acceptable as guidance will be provided. High intelligence required. A steep learning curve will be necessary to learn various regulations. Job Type: Full-time Application Question(s): Please describe your greatest accomplishment. Please provide any metrics that would be useful in understanding your credentials. For example, metrics that describe your academic experience, intelligence, test scores, team sizes you've worked with, etc. Location: Biotechnology - Nowshera Cantonment, Pakistan
#J-18808-Ljbffr
Opening Statement:
This is a unique and challenging position. We are seeking a lead programmer obsessed with product and company success. We are offering competitive starting pay with the opportunity for major incentives/raises/bonuses. Expectations are high and the selected candidate will be responsible for leading the programming department and learning/applying new skills specific to this position. This position will inherently require that the applicant be adaptable. A thorough understanding of systems and Software Development Lifecycle (SDLC) is required. The core product is programmed in SWIFT and runs on an iPad Pro 11-inch tablet using the Apple Pencil 2 Stylus. Our backend uses a combination of the following: EC2 instances with Django, Gunicorn, and Nginx; AWS cloud, Amazon RDS (PostgreSQL), S3 and Amazon CloudFront, and Heroku. Please note that some of these components might have changed in the newest release and the new team is able to restructure them. We also utilize an admin panel website and various API/SDK’s from 3rd party apps and unrestricted open-source code. Job Specification
Key Responsibilities: Transition and Transform Current Software Prototype: Lead transition process from old software team to you and your team. Assist in creation of a small team of 2-3 core programmers. Manage SDLC: Drive all stages of the Software Development Life Cycle (SDLC), ensuring our medical device software aligns with FDA guidelines & IEC 62304 from prototype to deployment and maintenance. Architecture & Programming: Pragmatically develop and improve software architecture by weighing pros and cons with options (e.g., determine when we should program aspects ourselves vs. using open source, API, out of the box solutions, etc.). Team Management: Lead our programming team and communicate with CEO when additional people are required full time or for specific contracted roles (e.g., we might hire a cybersecurity expert for 1 month of work). Regulatory Learning: It is likely that the applicant will not have experience in all required regulatory areas. As such, it will be mandatory for candidate to learn these regulations alongside the CEO and regulatory expert on the team. The selected candidate will need to comprehend regulations and ensure all clauses are systematically designed, implemented, and verified. Risk Management: Implement an effective risk management process that identifies and mitigates potential hazards throughout the software's lifecycle, in alignment with ISO 14971 standards. Quality Management: Establish a robust Quality Management System (QMS) per FDA's Quality System Regulation (QSR) and ISO 13485. Validation and Verification (V&V) Leadership: Direct and perform V&V activities ensuring that the software/device meet user needs, intended uses, and consistently fulfills all requirements. Design Control Procedures: Implement design controls in compliance with FDA regulations (21 CFR 820.30). Cybersecurity Governance: Address potential vulnerabilities, strategize, and oversee cybersecurity in compliance with FDA guidelines. Data Integrity and Security: Ensure robust data integrity, security, and compliance with laws like HIPAA and GDPR. Qualifications: Full stack programming background required. Clear experience and success in senior programming roles required. Prior experience in medical software and/or devices is recommended, but not required. Familiarity with regulatory standards (CFR 820, CFR 21 part 11, IEC 62304, ISO 13485, and relevant security guidelines) is beneficial, but the ability to learn and apply these regulations is also acceptable as guidance will be provided. High intelligence required. A steep learning curve will be necessary to learn various regulations. Job Type: Full-time Application Question(s): Please describe your greatest accomplishment. Please provide any metrics that would be useful in understanding your credentials. For example, metrics that describe your academic experience, intelligence, test scores, team sizes you've worked with, etc. Location: Biotechnology - Nowshera Cantonment, Pakistan
#J-18808-Ljbffr
This advertiser has chosen not to accept applicants from your region.
Be The First To Know
About the latest Medical device manufacturing Jobs in Pakistan !
3