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.
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