Senior Supplier Quality Engineer job in Exton, PA
Vacancy has expired
Exton, PA CorTech LLC
| Job Ref: | 340688 |
| Employer: |
CorTech LLC |
| Job Type: | Contract |
| Salary and Benefits: | 70.00/Per Hour |
| Remote: | No |
Location |
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| City: | Exton, PA |
| Post Code: | 19341 |
| Map: |
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Description |
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CorTech is seeking to hire a Senior Supplier Quality Engineer for our client in Exton, PA! Benefits Available! Weekly Pay! $70.00/Hour Purpose of the job To support the Business Unit regarding engineering activities for the ongoing and evolving stability and predictability of the supply chain. Interfacing with internal and external stake holders to appropriately qualify and maintain suppliers for all product lines. Expected tools to meet these requirements include supplier and component qualifications, data analysis, statistical process control (SPC), CAPA and KPI?s, review and trending. Supplier Quality is responsible for supplier product-related root cause analysis, process mapping and impact assessments for change control. Supplier Quality will lead in CMO/Supplier audits and associated downstream actions to meet Client expectations. As a senior member in the supplier quality engineering team, the senior supplier quality engineer is expected to provide subject matter expertise in supplier management, understand and evolve internal systems to efficiently meet requirements, interface with vendors of all sizes, and provide leadership to the supplier quality engineering team. Job Context Client medical device expertise spans one of the broadest portfolios of medical materials, including biostable polyurethanes, ultra-high molecular weight polyethylenes, resorbable polymers, ceramics, collagens, extracellular matrices, silicone hydrogels, device coatings, and drug delivery platforms. Millions of products are produced each year for applications in orthopedics, sports medicine, ophthalmology, general surgery and cardiology Within Client Biomedical: Lead supplier management activities Interface with internal stakeholders to lead and define deliverables for supplier qualification activities Own the Approved Supplier List and associated supplier statuses, risk assessments, and reviews Participate in product and process development activities to establish appropriate product requirements Understand Client manufacturing process capabilities Serve as technical subject matter expert resource for ISO 13485 and 21 CRF 820 Complete internal audits and process assessments as required Responsibility for supplier related nonconformances External to Client Biomedical: Communicate Client quality expectations to supply chain partners of all sizes Review and internally document execution of deliverables from supply chain partners Lead supplier audits/assessments Interface with suppliers through component validation activities, design validation strategies as needed Manage supplier corrective action process Review supplier-initiated change requests Lead and drive supplier improvements as necessary Job Content Key Areas of Accountability / Responsibility under limited supervision: Expected to serve as primary quality contact with vendors of all sizes and complexities Own and manage the supplier qualification process and Approved Supplier List Develop, document, and implement QA Procedures Analyze internal systems for improvement and drive the improvement efforts Perform external audits of CMOs/suppliers to appropriate criteria, report findings, and develop and track actions as required. Establish and negotiate Quality Agreements with required supply chain partners Analyze non-conforming materials and returned goods and recommend disposition and corrective actions Prepare, review, and approve technical reports and provide recommendations based on data rationale. Develop, lead, and review root causes for non-conformances and deviations Review documentation for completeness and accuracy Complete other tasks and projects as assigned by the Supplier Quality Assurance Manager Lead focused, multidisciplinary teams with clear objectives Serve as leader, teacher, and mentor to other supplier quality team members Work occasionally in a clean room setting following protective procedural requirements and comply with all safety requirements, including posted placards, SOPs and the Safety Manual. Adhere to Quality System procedures, ISO13485, 21CFR part 820 and current regulatory standards. SHE & Security It is the responsibility of each employee to work in a safe and responsible manner in order to create an injury-free and incident-free workplace. Comply with all job-related safety, security, and other training requirements. Report any SHE and Security incidents (including observed risks) to management Show behavior in line with the SHE and Security risks and agreed controls, including being compliant to Client and Client Biomedical requirements, rules, and procedures. Address any person behaving in a SHE and Security irresponsible way. Comply with Client Life Saving Rules. Complexity of the job Managing interaction with multiple departments; Change Management; Site based. Communicating technical reports to various internal and external personnel Knowledge and educational levelEducational Level: Bachelor?s degree in Engineering or Life Sciences Lead auditor certification Six Sigma, ASQ QE or CQA Certification a plus. Excellent organizational, leadership, decision-making, and analytical skills. Excellent written and verbal communication skills, including writing, editing and proofing skills. Well-developed inter-personal and teamwork skills to communicate and resolve product quality issues with R&D, Production, Engineering and other departments. Demonstrated ability to multi-task resulting in positive outcome for each task assigned or self-generated. Required level of experiences 8-15 years Quality Engineering or Supplier Management within a regulated industry: Medical Device, Pharmaceutical, Biotech. Experience with ISO 9001, or ISO 13485, or 21 CFR820 desired. Computer literacy (Microsoft Office, Project, Document Management Systems) Statistical techniques and software (i.e. ? Minitab) | |
ref: (340688)
1060 days ago
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