Supplier Quality Engineer II

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Supplier Quality EngineerProcurement & Purchasing

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Overview

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,

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Supplier Quality EngineerProcurement & Purchasing

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.

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.

Requirements

~3 min read

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 careers@integralife.com.

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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