Senior Quality Manager

The Senior Quality Manager oversees the Quality Management System (QMS) for the company's medical device products, ensuring compliance with regulatory standards such as ISO 13485 and FDA QSR. This role involves managing QA/QC teams, leading audits and inspections, and supporting cross-functional teams in new product development while promoting a culture of continuous quality improvement​.

Client Details

My client is highly regarded for its innovative contributions to the medical and biotechnology industries, especially through its osmometers and diagnostic equipment. The company fosters a supportive and collaborative work environment, offering excellent professional development opportunities. Employees appreciate its focus on continuous improvement, with regular training and mentorship to help staff grow in their careers. The company is also committed to customer-centric solutions, demonstrating strong leadership in its field. Additionally, my client enjoys a reputation for its respectful culture and emphasis on work-life balance

Description

Senior Quality Manager:

• 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.

Profile

Senior Quality Manager:

• 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.

Job Offer

• 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.
• Professional Development Opportunities: Training and advancement programs to help employees grow within the company.
• Wellness Programs: Encouraging a healthy lifestyle with various wellness initiatives.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.