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Senior Quality Engineer - Process Validation (FDA,CFR)

American Cybersystems, Inc. (ACS Group) Neenah Full-Time
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Title:                    Senior Quality Engineer - Process Validation (FDA,CFR)

Location:             Neenah WI 54956

Hours                   8-5 pm

Duration:            4 Months     


Note:

Quality System leader for Process validation. Looking for someone with strong experience in Class I and class II medical Devices. Top Skill sets, statistical sampling (applied Statistics) is required. Process validation experience, Six Sigma Black or green belt. FDA regulation 21 CFR 820 and ISO 1345 experience is required.


Position Purpose:

Provides high-level Quality/Regulatory leadership for assigned critical and complex quality systems, developing and improving those systems to deliver business results, routinely checking for compliance with standards, and providing training to customers/stakeholders.






Qualifications:

  • A Bachelor’s Degree in a relevant field, typically science or engineering-related
  • 8 years of broad experience in a Quality, Manufacturing, Research, or Regulatory function


Skills:

  • Six Sigma Certified Black or Green Belt, or ASQ-Certified Quality Engineer Certification is preferred
  •   Experience with Design of Experiments (DOE), Process Characterization and Validation, Gage R&R, and Risk Management tools (e.g. FMEA) is required
  • Strong analytical skills including statistical analysis are required
  • Experience with Batch/Blend, Cleaning & Sanitization, and Clean In Place validation to Cosmetic or OTC Drug standards is prefe
  • Understanding and application of appropriate medical device regulations, requirements and standards (including USFDA, Health Canada, TGA) as well as knowledge and experience with ISO 13485 and ISO 9001, and Regulation 21 CFR Part 820, Part 803) is required

Recommended skills

Iso 13485
Iso 9000
Failure Mode Effects Analysis
Research
Certified Quality Engineer
Quality Management Systems
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