Manager Quality Systems & Compliance – Medical Device

Our client is a commercial-stage medical device company dedicated to improving patient outcomes through innovative products. With a focus on excellence and quality, they are at the forefront of the medical device industry, delivering cutting-edge solutions to healthcare providers globally.

Position: The Manager of Quality Systems and Compliance will be responsible and accountable for compliance with US FDA regulatory requirements and company procedures and policies.  This position is a key interface between all functions within the company that execute activities pertaining to 21 CFR Parts 820 and 803.

Responsibilities:

• Ensure full compliance with 21 CFR 820, 21 CFR 807, 21 CFR 803, ISO 14791, FDA Guidelines
• CAPA, Risk Management, and other relevant FDA, ISO, ICH, and Industry Standards and Guidelines.
• Developing, implementing, and maintaining the Quality Manual and Quality Management System (QMS).
• Ensuring all QMS Element SOPs comply with applicable regulations.
• Manage the Document Control QMS Element, including an electronic Document Management system and compliance with FDA requirements and the Record Retention Policy.
• Managing the CAPA program.
• Manage the Quality Engineering function, ensuring proper tools and processes for administration of the QMS. 
• Managing the Internal Audit Program to prevent unfavorable FDA Inspection outcomes.
• Managing a team with responsibility for the execution of the QMS.
• Managing key aspects of the Front Room during FDA Inspections and third-party audits, such as the documents requested/reviewed log and daily transcripts.  
• Leading the Back Room during FDA Inspections and third-party audits.
• Leading the Escalation to Management Process; developing slide decks/overviews, and meeting minutes for Escalation to Management and Quality Review Board Meetings.
• Creating and presenting metrics for quarterly Quality Management Review Meetings; maintaining Quality Management Review slide decks and preparing Quality Management Review Meeting minutes.
• Managing the GMP Training QMS Element and associated IT Tool(s) used for training curriculum and training records.
• Leading Field Action Tactical Team(s).
• Conducting GMP training for all employees annually.
• Maintaining a strong collaborative partnership with cross-functional team members to facilitate a favorable compliance profile, protect patient/user safety, comply with all applicable Regulations, and meet business needs.
• Maintaining positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.

Requirements:

• Quality Management System Protégé or Mastery level knowledge and expertise
• Product Knowledge Student or Protégé level knowledge and expertise
• First-hand knowledge of Infusion Pump Technology and Software as a Medical Device.
• General Quality Assurance and Quality Systems Protégé or Mastery level knowledge and expertise.

Qualifications:

• BS degree in Engineering and/or science discipline; MS degree in Engineering and/or science discipline preferred.
• Seasoned Quality professional/leader with 5-8 years of experience, including people management, in the medical device industry, preferably in developing and maintaining Quality Management Systems for Class II or III medical devices.
• Demonstrated applied knowledge of regulatory requirements for Medical Devices (ISO 14971 and 21 CFR 820 at a minimum).
• Demonstrated leadership experience through formal and informal assignments.
• Results-orientated, multi-tasker, and quick learner; understands and responds to urgency.
• Able to successfully manage workload to timelines.
• Excellent verbal, written, and interpersonal skills.
• Applied knowledge of Microsoft Office software including Excel, Word, and PowerPoint

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