Integra LifeSciences · 1 week ago
Associate Manager, Quality Compliance
Braintree, MA
Full-time
Onsite
Mid, Senior Level
$94K/yr - $130K/yr
5+ years expIntegra LifeSciences is a company focused on creating change and shaping the future of healthcare. The Associate Manager, Quality Compliance is responsible for supporting the development and maintenance of the Quality Management System (QMS) at the Braintree site, ensuring regulatory compliance and leading key compliance programs. This role also involves providing guidance to Quality Compliance personnel and collaborating with cross-functional teams.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
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
Qualification
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
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
Ability to work cross-functionally, influence without authority, and support a culture of quality and compliance
Preferred
Experience supporting external audits, including backroom coordination; experience with FDA inspections strongly preferred
ASQ certifications (e.g., CQA, CQE) are a plus
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Savings plan (401(k))
Company
Integra LifeSciences
Integra LifeSciences is an integrated medical device company.
1001-5000 employees
H1B Sponsorship
Integra LifeSciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (5)
2023 (4)
2022 (7)
2021 (5)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$350M2018-05-15Post Ipo Equity· $350M
1995-08-25IPO
Leadership Team
Mojdeh Poul
Chief Executive Officer
Lea Knight
EVP and Chief Financial Officer
Recent News
Integra LifeSciences Holdings Corporation
2025-12-02
Company data provided by crunchbase