Responsibilities :
- Lead the implementation and maintenance of the Quality Management System across the organization, ensuring compliance with FDA, EU MDR, and other regulatory requirements.
- Act as the Business Process Owner, driving the end-to-end processes for Document Control, Change Control, Training, CAPA, Nonconformances, Complaint Handling, and Risk Management.
- Oversee the Centers of Excellence related to training, document control, and regulatory processes, ensuring compliance and process improvement.
- Collaborate closely with development and manufacturing teams to ensure adherence to regulatory standards and process compliance.
- Manage the end-to-end complaint workflow, including investigation, corrective / preventive actions, and reporting, ensuring accurate data integrity for trending analysis.
- Develop and monitor global Quality Assurance and Regulatory Affairs (QA / RA) Key Performance Indicators (KPIs), providing regular updates to the leadership team.
- Lead and mentor a team of quality professionals, fostering a positive work environment and ensuring the achievement of defined performance outcomes.
Requirements :
- Bachelor’s degree in Science or Engineering with 8+ years of experience in the medical device or pharmaceutical industry.
- 5+ years of leadership experience in Quality Assurance or Regulatory Affairs within a medical device or pharmaceutical environment.
- Strong experience in an ISO 13485 manufacturing environment; experience in contract manufacturing is a plus.
- Proven track record of Quality execution, including strategy development and metrics.
- Strong analytical skills with attention to detail, and demonstrated experience with Project Management.
- Excellent interpersonal and communication skills, with the ability to work effectively through influence and relationships.
- Ability to lead and manage a team, driving cross-functional collaboration and fostering a culture of continuous improvement.
- Experience working with electronic Quality Management Systems (eQMS) is preferred.
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