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Senior Supplier Quality Engineer.US-IRN.001

Posted on Jan 14, 2022 by Integra LifeSciences

Irvine, CA
Immediate Start
Annual Salary

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

Ensures comprehensive measurement systems in place to monitor supplier quality/reliability, and to identify, correct and prevent defects

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

Participates in and leads continuous improvement projects and initiatives

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

Participates and supports internal and third party audits / inspections

Conducts internal audit as required

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 is required.  Candidates with an equivalent combination of education and experience will also be considered for the position.

Experience working in a Medical Device manufacturing environment is preferred. 

Operations supplier quality experience, with a strong understanding of process validation (IQ, OQ, PQ) highly desired

Minimum 3 years of professional work experience in a GMP and /or ISO regulated industry is required

Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC, 21 CFR part 820

Strong communication, teamwork, and organizational skills are a must

Strong analytical problem solving and root cause analysis skills

Auditing background is preferred

Use of ERP, PLM systems

Use of Microsoft office tools

Knowledge of statistical techniques

Experience or knowledge with the machining processes, injection molding, and/or electro-mechanical components/assembly is preferred

Reference: 61849459

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