Corporate Quality Manager Jobs (NOW HIRING)

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The Director, Corporate QMS is a senior Quality executive responsible for establishing, leading, and continuously improving the global Quality Management System (QMS) across the Integra Lifesciences’ organization of design, manufacturing, and distribution sites worldwide. This role has full enterprise accountability for ensuring that the corporate QMS is strategically designed, effectively deployed, and consistently executed across all global sites, while maintaining full compliance with FDA medical device regulations (21 CFR Part 820), MDSAP requirements, ISO 13485, and other applicable international standards. In addition to enterprise leadership, this position serves as the Site Quality Leader (SQL) for the Princeton, NJ corporate office, an FDA‑registered and ISO 13485‑certified facility. The Director ensures the site is continuously audit‑ready, leads all regulatory inspections, and oversees site‑level quality system execution and compliance. The role leads global teams responsible for document control, training administration, management controls, technical writing, and regulatory response management, and acts as a key advisor to executive leadership on Quality strategy, compliance risk, and business performance.

Received: Direct supervision of the VP / Functional Quality Leader.
Exercised: Direct leadership of Corporate QMS functions including: Document Control & Records Management, Training Administration, Management Controls (Quality Policy, Objectives, Planning, Metrics, Management Reviews), Technical Writing & Regulatory Response Team. Indirect leadership across global site Quality and Supply Chain team members and cross‑functional global stakeholders.

1. Enterprise QMS Strategy & Leadership: Own and execute the global QMS strategy, ensuring integration of document and record control, training administration, and management control processes. Define the strategy for a global QMS, and develop and maintain a unified global QMS aligned with business strategy and regulatory requirements. In coordination and collaboration with the Enterprise Compliance Master Plan (ECMP), drive standardization, harmonization, and scalability of QMS processes across ~20 global sites with FDA‑registered and/or ISO‑certified quality management systems. Establish corporate governance for QMS processes and ensure consistent deployment and adherence. Lead enterprise QMS transformation initiatives, including process redesign and system enhancements.

2. Regulatory Compliance & Global Standards: Ensure full compliance with FDA 21 CFR Part 820, ISO 13485, MDSAP, EU MDR, and other global regulatory requirements. Serve as a senior Quality authority and point person for regulatory inspections, communications, and compliance strategy. Monitor evolving regulations and proactively implement changes across the QMS. Establish and maintain inspection readiness programs across all sites.

3. Princeton Site Quality Leadership: Serve as the Quality Management Representative and Site Quality Leader for the Princeton, NJ facility. Leveraging the Corporate Quality Compliance team, ensure the site maintains continuous audit readiness for FDA inspections and Notified Body audits. Lead all regulatory inspections (FDA, ISO, MDSAP), including preparation, hosting, and response coordination. Oversee site‑level quality processes, ensuring alignment with corporate QMS and regulatory expectations.

4. Management Controls (Corporate Quality Governance): Own and maintain the Enterprise‑wide Quality Policy, Quality Manual, and corporate quality objectives. Maintain enterprise quality planning processes aligned with strategic business goals. Define, oversee, and revise quality metrics and performance monitoring systems. Lead monthly data review board process; lead quality management review processes at Princeton site, divisional, and corporate levels. Ensure robust governance, escalation, and decision‑making frameworks for quality performance.

5. Document Control, Change Control & Records Management: Lead the global and site‑based document and records control program ensuring compliance, consistency, and efficiency. Oversee change control processes for the QMS, ensuring risk‑based prioritization and execution. Ensure lifecycle management of quality documentation across systems and sites. Maintain corporate record retention and archiving programs.

6. Training Administration & LMS: Own the global Quality System training program for global documents. Ensure compliance with training requirements, including 21CFRPart11 where applicable. Drive training effectiveness through metrics, audits, and continuous improvement.

7. Regulatory Response & Technical Writing: Leveraging the Technical Writing team, lead development and submission of timely regulatory responses, including FDA483 observations and Warning Letter updates. Oversee technical writing for QMS documentation and compliance communications. Ensure high‑quality, timely, and accurate regulatory documentation aligned with agency expectations.

8. Audit Readiness & Inspection Management: Leveraging the Corporate Quality Compliance team, establish and maintain a state of continuous audit readiness for the corporate site. Ensure the completion of required site‑level internal audits and host external inspections and audits. Ensure timely and effective response to audit findings, including CAPA and overall action effectiveness.

9. Quality Systems Performance & Continuous Improvement: Partnering with Quality Compliance Program Management, monitor QMS performance through data analytics and key performance indicators. Drive continuous improvement initiatives across all QMS processes. Identify systemic issues and lead root cause analysis and corrective actions.

10. Leadership & Organizational Effectiveness: Build and lead high‑performing global teams. Provide coaching and technical leadership across QMS disciplines. Influence senior leadership and cross‑functional teams. Foster a culture of quality, compliance, and operational excellence. Strategic Quality Leadership: Lead, execute, and provide expert guidance on enterprise Quality initiatives with significant regulatory complexity, including FDA Warning Letter responses, Form483 observations, Recall/field action activities, enterprise‑wide QMS change programs, manufacturing site remediation efforts involving complex CAPAs, and high‑risk Quality remediation initiatives. Provide executive‑level guidance on enforcement actions, remediation strategies, and regulatory commitments.

• Bachelor’s degree in engineering, life sciences, or a related technical discipline.
• 15+ years of progressive Quality experience within medical devices or similarly regulated life sciences industries.
• Demonstrated, hands‑on leadership of FDA remediation efforts, including Warning Letters or other enforcement actions.
• Extensive experience in QMS design, deployment, and transformation.
• Deep working knowledge of FDA QMSR / 21CFR820, FDA inspection and enforcement processes, ISO13485 and global standards and regulatory frameworks.
• Experience with QMS technologies (TrackWise, LMS, Agile or equivalent).
• Strong analytical skills, exceptional writing and interpersonal relationship skills.

• Strong experience with enterprise QMS software deployment and validation.
• Proven success in global process standardization initiatives.
• Ability to interface effectively with technical and non‑technical stakeholders.
• Strong organizational, prioritization, and multitasking abilities.
• Strong oral and written communication skills and effective interpersonal skills.
• Proficiency in Microsoft Office and quality systems tools.
• Willingness to travel (up to ~25%).

Ability to utilize a computer, telephone, copier, fax machine as well as other general office equipment, and industry‑standard Quality System applications.

The employee must repeatedly sit, listen, speak, and be able to travel by automobile or airline to Integra offices internationally as well as domestically. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 25 lbs.

General plant environment.

Formal application, rating of education and experience; oral interview and reference check; job related tests may be required.

The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.

Pay Range: $166,750.00 – $228,850.00 USD. Salary is determined by role, level, and location. Individual pay is determined by several factors including job‑related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Specific salary ranges for preferred locations will be shared during the hiring process.

Medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, group legal insurance, and savings plan (401(k)).

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you’d like more information on your rights under the law, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans. Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre‑existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position‑specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

Whatever your specialty, you’ll find an ideal setting for building a rewarding career. Along the way, you’ll have the satisfaction of knowing your work matters, that it’s making patients’ lives better, making a positive and lasting difference. You’ll find that the pace is exhilarating – because the need is so urgent. You’ll be challenged – and supported – by the most dynamic and inspiring people in your profession. And you’ll grow a career that is more impactful and fulfilling than you thought possible.