Supplier Quality Engineer II

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 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 solutions
• 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:

$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.

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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 [email protected].

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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