Terrific Contract Opportunity with a FULL suite of benefits!
Position: Sr. Quality Engineer
Location: Neenah, WI, 54956 or Remote
Term: 11 months
- Will need to “juggle” multiple projects- based on client needs.
- Will be working ON development teams. Research and engineering team. Quality functional expert on the R&E team.
- Ensuring appropriate design control activities are happening. (regulations are met, input from all the different regions etc).
Is this a good fit? (Requirements):
- A Bachelor’s Degree in a relevant field, typically science or engineering.
- 7 – 10 years of product development/design controls experience.
- Experience with medical device Regulation 21 CFR Part 820, Part 803 and applicable international quality standards and regulations including ISO 13485:2016, Canadian MDR, and EU Medical Device Regulation or regulations with transferrable requirements.
- Expert understanding and application of appropriate medical device regulations, requirements and standards
- Cross functional team experience
- Communication in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor
- Manage time working on multiple projects simultaneously
- Previous medical device/ product development experience. – required.
- Previous medical device / Regulation 21 CFR Part 820 – knowledge required
- Technical leadership- “someone that can help steer a team.”