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Senior Supplier Quality Engineer.US-IRN.001

Posted on Jan 14, 2022 by Integra LifeSciences

Irvine, CA
Research
Immediate Start
Annual Salary
Full-Time
Overview:



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



Qualifications:

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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