Icon hamburger
What job do you want?
Apply to this job.
Think you're the perfect candidate?
Apply Now

You’re being taken to an external site to apply.

Enter your email below to receive job recommendations for similar positions.

Senior Quality Engineer - Process Validation (FDA,CFR)

American Cybersystems, Inc. (ACS Group) Neenah Full-Time
Apply Now

Title:                    Senior Quality Engineer - Process Validation (FDA,CFR)

Location:             Neenah WI 54956

Hours                   8-5 pm

Duration:            4 Months     


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.


  • 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


  • 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
Certified Quality Engineer
Quality Management Systems
Apply to this job.
Think you're the perfect candidate?
Apply Now

Help us improve CareerBuilder by providing feedback about this job: Report this job

Report this Job

Once a job has been reported, we will investigate it further. If you require a response, submit your question or concern to our Trust and Site Security Team


For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.