Senior Quality Engineer Jobs at XXX DO NOT USE XXX WishBone Medical, Inc
Sample Senior Quality Engineer Job Description
Senior Quality Engineer
SUMMARY:
The position of Senior Quality Engineer is responsible for managing an efficient NPI program that is compliant to regulatory and corporate quality guidelines. The Senior Quality Engineer leads Quality improvements/CAPA/NCMR and audit responses.
ESSENTIAL DUTIES AND RESPONSIBILITIES: (includes the following but other duties may be assigned)
- Develop and apply quality standards in accordance with company and customer requirements. Develop and conduct related tests
- Lead by example, coach, consult, advice and/or train different levels of associates in problem-solving and in addressing quality issues and the systemic improvement projects
- Oversee, sustain, and report on the performance of the non-conforming material processes
- Manage and resolve internal and external customer issues and escalations
- Execute PFMEA/risk assessment to identify opportunities for improvements. Recommend corrective action for procedural, product, or process deficiencies
- Responsible for Quality improvements/CAPA/NCMR and audit responses.
- Design and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and/ or production equipment
- Utilize drawings, specifications, industry standards, and sketches, adapting inspection measuring devices and procedures when necessary. Read and interpret technical drawings and specification requirements
- Solve complex problems, take a new perspective on existing solutions, and exercise judgment based on the analysis of multiple sources of information
- Understand ISO13485, FDA's GMP, and ISO14971
QUALIFICATION REQUIREMENTS:
- 5+ years' experience in the medical device or pharmaceutical industry in preferred
- Internal Auditor or Lead Auditor credentials preferred
- Experience with MiniTab or other statistical software
- BS in Engineering
OTHER SKILLS and ABILITIES:
- Proficient in Microsoft Word and Excel
Current Openings for Senior Quality Engineer Jobs at XXX DO NOT USE XXX WishBone Medical, Inc
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