Senior Quality Manager

Senior Quality Manager

Job Description:

• Manage the Quality Assurance (QA) and Quality Control (QC) teams to support all operational functions.
• Oversee the site's Quality Management System (QMS), including CAPA, NCMR, and audits.
• Ensure compliance with regulatory standards such as ISO 13485 and FDA QSR.
• Lead internal and external audits and regulatory inspections.
• Support cross-functional teams in new product development to meet quality requirements.
• Review and approve product changes, ensuring compliance with design control procedures.
• Drive continuous improvement and foster a culture of quality.
• Develop and maintain relationships with key regulatory bodies and customers.
• Ensure timely and effective management review processes.
• Stay current on industry regulations and standards to guide internal practices.

Requirements:

• Possess a strong background in quality systems management for medical devices.
• Have at least 10 years of experience in quality management, particularly with in vitro diagnostics.
• Demonstrate expertise in ISO 13485, FDA QSR, IVDR and MDSAP regulations.
• Be an effective leader with at least 5 years of management experience.
• Have proficiency in managing audits, inspections, and compliance activities.
• Be skilled in risk management and validation processes.
• Exhibit excellent communication and organizational skills.
• Show commitment to fostering a culture of continuous quality improvement.
• Be adept at working cross-functionally in new product development.
• Stay current on evolving industry regulations and standards.

Professional Development:

• Professional Development Opportunities: Training and advancement programs to help employees grow within the company.

Job Benefits:

• Competitive compensation as well as a bonus.
• Hybrid work schedule.
• State of the art technology & facility.
• 401(k) Retirement Plan: With employer matching contributions to help employees save for retirement.
• Health Insurance: Including medical, dental, and vision coverage to support overall well-being.
• Paid Time Off (PTO): Generous vacation, sick leave, and holiday pay.
• Life and Disability Insurance: Coverage for both short-term and long-term disabilities.
• Wellness Programs: Encouraging a healthy lifestyle with various wellness initiatives.