Associate Manager, Quality Compliance

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. **SUMMARY DESCRIPTION** The Associate Manager, Quality Compliance supports the development, maintenance, and continuous improvement of the Quality Management System (QMS) at the Braintree site. This role provides leadership for key compliance programs-including CAPA, Nonconformance, Internal Audit, Quality Management Review, and Quality Metrics-and plays a critical part in ensuring ongoing regulatory compliance across site operations. The Associate Manager will also support external audit readiness and execution, including leadership of backroom activities, coordination of documentation, and engagement with subject matter experts. While this role has no direct reports, it provides day-to-day guidance to site Quality Compliance personnel and partners closely with cross-functional teams to ensure consistent, compliant processes. **ESSENTIAL DUTIES AND RESPONSIBILITIES** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. + Support the effective operation of the site Quality Management System (QMS), ensuring compliance with internal procedures, current Good Manufacturing Practices, and applicable regulatory requirements. + Lead the CAPA program, including CAPA Review Board (CRB) coordination, review of investigations, action planning, and overall phase execution. + Support the Nonconformance and Internal Audit programs, including planning, execution, follow-up, and documentation of audit responses and results. + Prepare and coordinate materials for Quality Management Review (QMR), including site metrics, trend analyses, and reporting against the Quality Objectives. + Provide leadership for backroom activities during external audits (e.g., Notified Body audits, FDA inspections), including document management, SME coordination, and response strategies. + Prioritize activities and projects to ensure timely completion of compliance obligations and remediation commitments. + Lead or support quality improvement initiatives and cross-functional compliance projects as assigned. + Develop and maintain compliance documentation, including audit responses, CAPA records, metrics, and QMS summaries. + Serve as a resource to CAPA, NC, and Audit personnel, providing coaching and guidance to strengthen understanding of quality system requirements. + Support escalation, communication, and reporting of quality system risks or concerns to site leadership. + Perform other duties as assigned. **DESIRED MINIMUM QUALIFICATIONS** The requirements listed below represent the knowledge, skill, and ability required. + Bachelor's degree in Engineering, Life Science, or related field with **5+ years** of experience in Quality Assurance, Quality Compliance, or a related discipline within the medical device or similarly regulated industry + Master's degree with **3+ years** of experience, or + Doctoral degree with **0-2 years** of experience may be considered + Working knowledge of applicable regulations and standards, including: + 21 CFR 820, 803, 806; Part 11; Part 4 + ISO 13485 + MDSAP requirements + Global regulatory expectations (ANVISA, Health Canada, TGA, EU, etc.) + Demonstrated experience with CAPA processes, investigational techniques, root cause analysis, and verification of effectiveness practices. + Experience supporting external audits, including backroom coordination; experience with FDA inspections strongly preferred. + Strong written and verbal communication skills, with proven ability to draft and review regulatory and quality system documentation. + Familiarity with quality metrics, data analysis, and trend identification. + Strong critical thinking, problem solving, and analytical abilities. + ASQ certifications (e.g., CQA, CQE) are a plus. + Ability to work cross-functionally, influence without authority, and support a culture of quality and compliance. Salary Pay Range: $94,300.00 - $129,950.00 USD Salary Our salary ranges are 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 **.** Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following 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 [email protected]. Unsolicited Agency Submission 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. 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