Accentuate Staffing is seeking a highly experienced and motivated Senior Manager of Quality Systems to lead and oversee the development, implementation, and maintenance of our Quality Management System (QMS). The successful candidate will ensure that our QMS is fully established and compliant with applicable regulatory standards, including FDA, EU MDR, and other relevant bodies. This role involves close collaboration with cross-functional teams to drive continuous improvement and maintain the highest standards of quality in our processes and products.
Key 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.
Qualifications:
- 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.
