Sr Quality Engineer
Katalyst Healthcares and Life Sciences
Job Description:
Responsibility for the Quality and Compliance of process development and manufacturing of implantable ( Class III) Cardiac and Neuromodulation medical device related products. Initial scope of work may be focused on Inspection Optimization projects in addition to other duties supporting Quality in manufacturing operations of microelectronics assembly and IC and Wafer assembly.
Responsibilities:
Required Skills:
Responsibility for the Quality and Compliance of process development and manufacturing of implantable ( Class III) Cardiac and Neuromodulation medical device related products. Initial scope of work may be focused on Inspection Optimization projects in addition to other duties supporting Quality in manufacturing operations of microelectronics assembly and IC and Wafer assembly.
Responsibilities:
- Leading and managing Inspection Optimization projects that span different processes in our microelectronics assembly line. Including both manual visual inspection and automated/semi-automated inspection methods.
- Support manufacturing development and continuous improvement as the Quality team member for process development and validation including Equipment Development, IQ, Process Characterization, & OQPQ ensuring compliance and rigor.
- Partnering with process engineers on development of Test Methods and Test Method Validation plans and execution. Spans both attribute and variables TMVs (Gage R&Rs/MSAs).
- Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Required Skills:
- Bachelor of Engineering degree and minimum of 4 years of relevant experience OR Master's Engineering degree with a minimum of 2 years relevant experience
- 4+ years of engineering experience in a medical device manufacturing environment
- 4+ years of Process Quality or Process Engineering experience.
- Strong background in Equipment Development, IQ, Process Characterization, OQPQ, and Test Method Development and Validation.
- Experience with electronics manufacturing including wafer fabs and microelectronics assembly (SMT and/or chip and wire).
- Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.).
- Technical Structured Problem Solving methodologies (e.g. DMAIC, Ishikawa, 8D, etc.).
- Proficiency in Microsoft Office Applications (Word, Excel, PowerPoint, Teams).
- DRM or DFSS certification.
- Experience with internal and external audits including FDA, MDSAP and/or TUV.
- Six Sigma or Lean Sigma belt certification.
- Strong statistical analysis techniques & DOE design and execution.
- Strong understanding of medical device manufacturing processes and products.
Vacancy posted 4 days ago
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