Supplier Quality Engineer II

Integra LifeSciences; Mansfield (MA); On-site; USD 71,000 - 98,000; Full time

Job summary

Integra LifeSciences in Mansfield, MA, seeks a Supplier Quality Engineer II to lead QA activities with contract manufacturers and raw material suppliers, ensuring compliance with FDA 21 CFR Part 820, ISO 13485, and related regulatory requirements.

The ideal candidate will manage supplier audits, performance metrics, CAPA and change control, quality agreements, and provide technical support to QC, manufacturing, and purchasing to drive continuous improvement and reliable product supply.

Qualifications

• Bachelor’s degree in engineering, life science, or related technical discipline.
• Minimum 3 years of professional work experience in a GMP and/or ISO regulated industry.
• Knowledge of ISO13485, 93/42/EC, and 21 CFR Part 820 regulations.
• Strong communication, teamwork, and organizational skills.
• Experience with ERP, PLM systems and Microsoft Office; knowledge of statistical techniques.

Responsibilities

• Provide quality assurance leadership to select contract manufacturing sites and raw material suppliers.
• Establish and maintain the Approved Supplier List.
• Plan and execute supplier audits.
• Conduct supplier audits according to GMP, ISO standards and regulatory requirements.
• Establish and ensure Supplier Quality Agreements are up to date and manage supplier change control.
• Report on contract manufacturer performance metrics and provide support to QA, purchasing and production.

Skills

Communication skills

Teamwork

Organizational skills

Analytical thinking

Root cause analysis

Education

Bachelor's degree in Engineering/Life Science

Tools

ERP

PLM

MS Office

Statistical tools

Job description

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.

Job Summary

This Supplier Quality Engineer II role serves as a key quality representative supporting contract manufacturers and raw material suppliers involved in the production of Integra products. The position is responsible for supplier audits, supplier performance monitoring, CAPA and nonconformance management, supplier change control, quality agreement management, and validation activities while ensuring compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulatory requirements.

The ideal candidate will have experience working in a regulated medical device or life sciences environment and possess a strong understanding of supplier quality systems, root cause investigations, and quality engineering principles. This role partners closely with Quality Control, Manufacturing, Purchasing, and supplier organizations to drive continuous improvement, resolve quality issues, and ensure supplier compliance. It is an excellent opportunity for a quality professional looking to influence supplier performance, support business continuity, and contribute to the delivery of safe and effective medical products.

Job Description

• Provides quality assurance leadership to select contract manufacturing sites and raw material suppliers engaged in the production of Integra products
• Establishes and ensures the Approved Supplier List is up to date
• Establishes timely planning and execution of supplier audits
• Conducts Supplier Audits according to good manufacturing practices, ISO Standards, and applicable regulatory requirements
• Establish and ensure Supplier Quality Agreements are up to date for applicable suppliers engaged in the production of Integra products
• Report on contract manufacturer performance metrics
• Ensure technical support to QC, purchasing and production departments
• Provide Quality Engineering Support to suppliers including audits/assessments, inspection technique support, verification /validation activities, CAPA and change management. FDA CFR part 820 and ISO 13485 regulations/standards will be the focus.
• Addresses Supplier Change Requests in compliance with procedures and regulatory requirements

Requirements

• Ensures that activities for validation of outsourced processes/products are performed and documented according to procedures and within the defined timeline
• Ensures that Supplier Non-conformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements
• Escalate supplier quality issues to management as appropriate, develop and propose robust and compliant solutions
• Manages or participates in quality projects as required
• Provides support with complaint investigations as required
• A minimum of a Bachelor’s Degree in an Engineering, Life Science, or a related technical discipline. Candidates with an equivalent combination of education and experience will also be considered for the position.
• Minimum 3 years of professional work experience in a GMP and /or ISO regulated industry.
• Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC, 21 CFR part 820.
• Strong communication, teamwork, and organizational skills are essential
• Strong analytical problem solving and root cause analysis skills
• Use of ERP, PLM systems
• Use of Microsoft office tools
• Knowledge of statistical techniques

Preferred

• Experience working in a Medical Device or Life Science manufacturing environment.
• Operations supplier quality experience, with a strong understanding of process validation (IQ, OQ, PQ).
• Auditor Certification to ISO 13485:2016.
• Experience or knowledge with the machining processes, injection molding, and/or electro-mechanical components/assembly.

Salary Pay Range:

$71,300.00 - $97,750.00 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 Total Rewards | Integra LifeSciences

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 [e-mail].

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