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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.

The Lead Quality Assurance Coordinator (formerly, Quality Assurance Specialist II) supports QA oversight of the Integra Boston/Braintree GMP Manufacturing Facility. This individual works collaboratively with Manufacturing, Engineering, Quality Control, and other functional experts to review the output of daily operational activities. Additionally, the QA Specialist II provides QA department activity oversight

Performs the essential duties and responsibilities as listed in section below.

• Review of production activities including completed forms and batch records against procedure requirements and product specifications for material and product release.

• Review of quality monitoring and testing activities including environmental monitoring and product surveillance.

• Supports QA procedure changes including writing, revising, training and implementation.

• Conducts training for staff at all levels as it relates to quality assurance review and release procedures. Compiles quality metrics for daily/weekly/monthly reporting and reports metrics to site management

• Compiles information for Quality Management Review

• Conducts inspections of materials

• Reviews records for compliance to procedures such as inspection reports, test records, and Device History Records

• Conducts CAPA investigations, proposes corrective and preventative actions, and conducts verification and effectiveness reviews Initiates Nonconforming Material reports, conducts nonconformance investigations, and presents reports/metrics during periodic meetings

• Participates in audits/inspections by customers and regulatory agencies and compiles corrective and preventative action responses

• Other duties may be assigned as necessary

MINIMUM QUALIFICATIONS:

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position:

• Ability to support 2 shift operations as necessary (between 6:00am – 5:30pm EST).

• Associates Degree with related work experience is required. A Bachelor’s Degree is preferred.

• 5+ years’ experience in a Quality/Regulatory Compliance environment.

• Familiarity with application of FDA and/or ISO quality standards in a government regulated industry.

• Moderate computer competence, including experience with database and Microsoft Office.

• Knowledge of QA terms, tools, and methodologies.

• This role will start based in our South Boston facility, then transition to our new facility on 400 Wood Rd in Braintree

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.

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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 or call us at 855-936-2666.

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