Supplier Quality Engineer II
ResponsibilitiesProvides 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 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 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, EUMDR Auditor Certification to ISO 13485:
2016 highly desired 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
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
2016 highly desired 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
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
