Reporting to: Quality Director
Location: Brookfield, CT
We are currently seeking a Quality Engineerto join our team and report to the Director of Quality out of our Brookfield, CT headquarter space. In this role, the candidate will ensure that processes needed for the quality management system are established, implemented, and maintained. This person will support the manufacturing line, research and development for high value hardware development, qualification, acceptance, and production testing. The candidate will also report on the performance of the quality management system and any need for improvement.
Duties and Responsibilities
- Design and review project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements.
- Work with the Design, Development Engineering, Technical Sourcing, Regulatory Affairs, Quality, and other cross-functional partners to clarify design intent, identify critical features, and assess feature risk to implement the quality/reliability objectives for each component using knowledge of past performance, use conditions, therapy performance and product function, user needs.
- Audit, monitor, and witness test processes for compliance with requirements and keeping a watchful eye for risk opportunities
- Ability to participate in gathering of QA Engineering metrics gathering and compiling for higher level review.
- Communicate regularly with Manufacturing and Test counterparts, and proactively engage in issue resolution
- Minimum Experience: 5+ years of experience in Medical Device Industry
- Preferred: B.S. degree in Engineering, Math, Physical Science, or equivalent field
- Expert knowledge of 21 CFR Part 820 (CGMP)
- Ability to thrive in a start-up environment.
- Excellent interpersonal and communication skills.
- Problem analysis and problem resolution skills.
- Strong knowledge of quality management systems and manufacturing processes.
The right candidate will be comfortable working with a small team and have a good balance of “doing things right” (quality, experience) and thinking outside the box / flexibility. We are a group of driven and passionate individuals and look for someone to have the same level of excitement for their work. We work hard but have a great time while doing so, mostly because of the great people we work with.
If this sounds like the position and company that you are looking for, please submit:
- A cover letter detailing why you are the ideal fit for this job (note: applications without a personal cover letter will not be considered)
- An up-to-date resume
Finally, openness, honesty, and candidness are qualities we respond to—as opposed to framing things in the right way with the right words. Please be who you are and let the dice roll.