Supplier Quality Engineer II

INTEGRA LIFESCIENCES PRODUCTION CORPORATION; Mansfield (MA); On-site; USD 71,000 - 98,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life insurance

Disability Insurance

401(k)

Job summary

Integra LifeSciences is seeking a Supplier Quality Engineer II to lead supplier QA activities at contract manufacturers and raw material suppliers, ensuring compliance with FDA 21 CFR Part 820 and ISO 13485. This role focuses on audits, CAPA, supplier quality agreements, and change control.

You will collaborate with QC, Manufacturing, and Purchasing to improve supplier performance and support business continuity in a regulated environment, based in Mansfield, MA.

Qualifications

• Bachelor’s degree in Engineering, Life Science, or related technical discipline.
• Minimum 3 years of professional work experience in GMP/ISO regulated industry.
• Knowledge of ISO13485, 93/42/EEC, 21 CFR part 820.
• Strong communication, teamwork, and organizational skills.
• Strong analytical problem solving and root cause analysis skills.
• Experience with ERP/PLM systems and MS Office.
• Knowledge of statistical techniques.

Responsibilities

• Lead quality assurance for contract manufacturers and suppliers.
• Maintain Approved Supplier List and audit schedules.
• Conduct supplier audits per GMP/ISO and regulatory requirements.
• Manage Supplier Quality Agreements and supplier change control.
• Provide QA support to QC, purchasing, and production.
• Support CAPA, investigations, and validation efforts for outsourced processes.
• Escalate supplier quality issues and drive compliant solutions.

Skills

Quality assurance

Regulatory compliance

Root cause analysis

ERP systems

PLM systems

Microsoft Office

Statistical techniques

Education

Bachelor's degree in Engineering or Life Science

Tools

ERP

PLM

Microsoft Office

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
• 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 solutionsli>
• Manages or participates in quality projects as required
• Provides support with complaint investigations as required

Job Requirements

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

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.

Benefits

• medical
• dental
• vision
• life insurance
• short- and long-term disability
• business accident insurance
• group legal insurance
• savings plan (401(k))

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].

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.

Integra - Employer Branding from Integra LifeSciences on Vimeo 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 then you thought possible. More than 4,200 Integra employees already know we’re a great place to build a career. Here’s your chance to discover that for yourself.