Misco Jobs

Quality Assurance Engineer - Quality/Manufacturing/Medical 65-75 K/yr

Posted: 13 Oct 2008
Apply Deadline: 8 Jan 2009
Location: Philadelphia, PA, USA
Our medical device client in SE Pennsylvania is ACTIVELY SEARCHING for a Quality Assurance Engineer! Main responsibilities of this position will be to develop, implement and maintain quality system requirements and practices in assigned areas of Manufacturing, Supplier Management, Process Validation and New Product Development. Some additional key areas of responsibility will be: CAPA, non-conforming product, calibration systems, supplier auditing, measuring techniques and facilitating root cause analyses.
Successful candidates MUST HAVE a Bachelors degree in Engineering, a related Science field or Business; at least 4 years experience in a QA role in a manufacturing environment (ideally 2 years in medical device or pharmaceuticals); strong knowledge of and experience in Statistics and Statistical Process Control and Design of Experiments, and good working knowledge of geometric dimensioning and tolerance, blueprint reading, gauge design, basic metrology and quality plan development. Strong Pluses: knowledge of the FDAs QSR and ISO regulations, certifications in ASQ Certified Quality Engineering, Lean Manufacturing, or Six Sigma. Salary is commensurate with experience and knowledge, performance-based annual bonus and very competitive benefits. Relocation assistance is available for the right candidate.
Questions you will be asked:

• Over the last 2 to 5 years, what quality initiatives have you either led or been a critical part of?

• Briefly describe how these initiatives benefited your company or organization.

• What Statistical tools and-or methods have you used most extensively?

• Where do you currently live? Why do you want to relocate to SE Pennsylvania?

Related Words: manufacturing engineer, medical device, pharmaceutical, pharma, med device, device manufacturing, plastics, biomaterial, molded material, molded plastic, biomedical, implant, implant device, process validation, capa, calibration system, sterile device, tool design, gauge design, statistical analysis, statistics, root cause analysis, fmea, pfmea, food and drug regulations, fda regulations, geometric tolerance, geometric dimension, metrology, statistical process, design of experiement, asq, asq certification, lean manufacturing, lean engineering, bsme, bsie, six sigma, anodization, passivation, electopolish, electro-polish, machining, sheet metal fabrication, quality engineer, quality assurance

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