Medical Device - Quality Specialist
??We are looking for Medical Device - Quality Specialist for our client in West Chester, PA
Job Title: Medical Device - Quality Specialist
Job Location: West Chester, PA
?US citizens and those authorized to work in the US are encouraged to apply. We are unable to sponsor H1b candidates at this time.?
EDUCATION & EXPERIENCE REQUIREMENTS:
- A minimum of a Bachelor?s Degree is required.
- A minimum of 2years of experience in Quality and/or Compliance within the Medical Device Industry and/or Pharmaceutical Industry is required.
- Specific experience in corrective and preventive actions is preferred.
- Working knowledge of 21 CFR Part 820 and ISO13485 is required.
- A certification in Process Excellence (e.g. Green Belt) is an asset.
- Experience with front and back room is strongly preferred.
- A demonstrated proficiency in process improvement methodology and use of investigative tools (Cause and Effect Diagrams, Trend Analysis, Capability Analysis, Control Charts, Pareto Charting, etc.) are preferred.
- Demonstrated ability to work effectively with cross-functional teams for problem-solving, product and process improvement is required. Organizational and communication skills providing the ability to multi-task in a fast-paced environment are required.