Manager, Quality Assurance

QA Manager, USA
Location: Hybrid in NH or PA

Are you an experienced Quality Assurance professional with a passion for compliance, continuous improvement, and leadership? We are seeking a Quality Assurance Manager to join a new Quality team and lead QA operations in the USA for a local medical device company. In this role, you will drive compliance strategy, oversee quality systems, and ensure medical device products meet the highest regulatory standards.

Key Responsibilities:

• Develop and execute the organizational and compliance strategy for QA in the USA in collaboration with the Chief Compliance Officer (CCO).
• Oversee all Quality Assurance processes, including FDA communication and compliance.
• Maintain and enhance the Quality Management System (QMS) to align with global standards and regulatory requirements.
• Ensure product release compliance with regulatory-approved specifications (PRRC for product release and sterilization).
• Lead internal audits and report compliance levels through management review and oversight meetings.
• Drive continuous improvement initiatives for increased efficiency, effectiveness, and compliance.
• Prepare for and manage external audits while resolving non-conformities.
• Educate, train, and advise teams on quality and compliance matters.
• Own and drive the Corrective and Preventive Action (CAPA) process, including field safety corrective actions.
• Act as the Management Representative for the USA.
• Lead, mentor, and develop the Quality team.

Qualifications:

• 5+ years of experience in a senior Quality Assurance role within a regulated industry, preferably medical devices.
• Strong knowledge of major regulatory frameworks (e.g., FDA, ISO 13485).
• Experience managing FDA inspections and/or Notified Body audits.
• Proven ability to translate complex quality requirements into actionable processes.
• Strong background in production and distribution quality oversight, preferably in disposable medical devices.
• Exceptional project management skills, ability to prioritize based on business needs.
• Experience leading teams and working in a multi-national and multi-functional environment.
• Open-minded, solution-driven, and committed to continuous improvement.
• Excellent interpersonal and communication skills.