Fresenius Kabi USA, LLC
Medical Device QMS Project Manager
Fresenius Kabi USA, LLC, North Andover, Massachusetts, us, 01845
Job Summary The Medical Device Quality Management System (QMS) Project Manager is responsible for planning, executing, and overseeing projects related to the development, enhancement, and maintenance of the Quality Management System (QMS) in compliance with regulatory standards. This role requires strong project management skills to ensure that QMS initiatives are completed on time, within scope, and in alignment with organizational objectives. The QMS Project Manager will work closely with cross-functional teams, including quality assurance, regulatory affairs, product development, and manufacturing, to drive continuous improvement in quality processes and ensure regulatory compliance. Responsibilities
1. Project Planning and Execution:Lead the planning, coordination, and execution of QMS-related projects, including new system implementations, process improvements, and regulatory compliance initiatives.
Define project scope, goals, deliverables, and timelines in collaboration with stakeholders.
Develop detailed project plans, including resource allocation, budget management, and risk assessment.
2. Stakeholder Collaboration:Work closely with cross-functional teams to ensure alignment of project objectives with organizational goals.
Facilitate communication between project teams, senior management, and other stakeholders to ensure project milestones are met.
Serve as the primary point of contact for project-related inquiries and updates.
Establish and lead an internal medical device QMS audit program serving as the lead auditor and/or leading audit teams consisting of other North Andover design center cross functional (R&D, IT, QA, etc.) team members.
3. Regulatory Compliance:Ensure that all QMS projects comply with relevant regulatory standards, including ISO 13485, and FDA 21 CFR Part 820.
Collaborate with regulatory affairs and quality assurance teams to ensure that project outcomes support ongoing compliance efforts.
4. Risk Management and Mitigation:Identify potential risks associated with QMS projects and develop mitigation strategies to address them.
Monitor and manage project risks throughout the project lifecycle, adjusting plans as necessary to minimize impact on timelines and outcomes.
5. Documentation and Reporting:Maintain comprehensive project documentation, including project plans, progress reports, meeting minutes, and risk registers.
Prepare and present regular project status reports to senior management and stakeholders.
Ensure that all project documentation is accurate, complete, and stored in compliance with QMS requirements.
6. Continuous Improvement:Identify opportunities for process improvements within the QMS and lead initiatives to implement these enhancements.
Promote a culture of continuous improvement by facilitating lessons learned sessions and applying best practices to future projects.
7. Training and Support:Provide training and support to project teams on QMS processes, tools, and best practices.
Mentor and guide team members in project management methodologies and quality standards.
The requirements listed below are representative of the knowledge, skill, and /or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* Bachelor's degree in a related field (e.g., Quality Management, Life Sciences, Engineering) required; Master's degree preferred.* Minimum of 5 years of experience in document management, training development, or a related role within the medical device or pharmaceutical industry.* In-depth knowledge of regulatory requirements for medical devices, including ISO 13485 and FDA 21 CFR Part 820.* Proven experience with document management systems (DMS) and electronic quality management systems (eQMS).* Strong leadership skills with experience managing teams and projects.* Excellent communication skills, with the ability to convey complex information clearly and concisely.* Experience in developing and delivering training programs, with a solid understanding of adult learning principles.* Detail-oriented with strong organizational and problem-solving abilities.* Proficiency in Microsoft Office Suite and other relevant software.Preferred Skills:* Certification in Quality Management (e.g., Certified Quality Auditor, Certified Quality Engineer).* Experience with Lean, Six Sigma, or other continuous improvement methodologies.* Familiarity with e-learning development tools (e.g., Articulate, Captivate).* Familiarity with the Propel eQMS system.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company match, andwellness program.Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
1. Project Planning and Execution:Lead the planning, coordination, and execution of QMS-related projects, including new system implementations, process improvements, and regulatory compliance initiatives.
Define project scope, goals, deliverables, and timelines in collaboration with stakeholders.
Develop detailed project plans, including resource allocation, budget management, and risk assessment.
2. Stakeholder Collaboration:Work closely with cross-functional teams to ensure alignment of project objectives with organizational goals.
Facilitate communication between project teams, senior management, and other stakeholders to ensure project milestones are met.
Serve as the primary point of contact for project-related inquiries and updates.
Establish and lead an internal medical device QMS audit program serving as the lead auditor and/or leading audit teams consisting of other North Andover design center cross functional (R&D, IT, QA, etc.) team members.
3. Regulatory Compliance:Ensure that all QMS projects comply with relevant regulatory standards, including ISO 13485, and FDA 21 CFR Part 820.
Collaborate with regulatory affairs and quality assurance teams to ensure that project outcomes support ongoing compliance efforts.
4. Risk Management and Mitigation:Identify potential risks associated with QMS projects and develop mitigation strategies to address them.
Monitor and manage project risks throughout the project lifecycle, adjusting plans as necessary to minimize impact on timelines and outcomes.
5. Documentation and Reporting:Maintain comprehensive project documentation, including project plans, progress reports, meeting minutes, and risk registers.
Prepare and present regular project status reports to senior management and stakeholders.
Ensure that all project documentation is accurate, complete, and stored in compliance with QMS requirements.
6. Continuous Improvement:Identify opportunities for process improvements within the QMS and lead initiatives to implement these enhancements.
Promote a culture of continuous improvement by facilitating lessons learned sessions and applying best practices to future projects.
7. Training and Support:Provide training and support to project teams on QMS processes, tools, and best practices.
Mentor and guide team members in project management methodologies and quality standards.
The requirements listed below are representative of the knowledge, skill, and /or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* Bachelor's degree in a related field (e.g., Quality Management, Life Sciences, Engineering) required; Master's degree preferred.* Minimum of 5 years of experience in document management, training development, or a related role within the medical device or pharmaceutical industry.* In-depth knowledge of regulatory requirements for medical devices, including ISO 13485 and FDA 21 CFR Part 820.* Proven experience with document management systems (DMS) and electronic quality management systems (eQMS).* Strong leadership skills with experience managing teams and projects.* Excellent communication skills, with the ability to convey complex information clearly and concisely.* Experience in developing and delivering training programs, with a solid understanding of adult learning principles.* Detail-oriented with strong organizational and problem-solving abilities.* Proficiency in Microsoft Office Suite and other relevant software.Preferred Skills:* Certification in Quality Management (e.g., Certified Quality Auditor, Certified Quality Engineer).* Experience with Lean, Six Sigma, or other continuous improvement methodologies.* Familiarity with e-learning development tools (e.g., Articulate, Captivate).* Familiarity with the Propel eQMS system.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company match, andwellness program.Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.