A leading Biotech company are actively seeking a motivated candidate to fill their Quality Engineer opportunity. This is an initial 12-month contract, with opportunity to extend/ convert to FTE. This is an on-site role based out of Minnesota with a salary range of $55-60/hr depending on experience.
- BS degree in an engineering or physical/life science field.
- 5+ years relevant experience within the medical device industry or related function (a combination of education and experience may be considered).
- Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance.
- Evaluate mechanical product design and identify potential design quality issues and drive technical decisions.
- Lead and support DHF and DMR content completion, integrity, and regulatory & standards compliance; collaboratively communicating and resolving gaps.
- Lead CAPA/NCR/SCAR/complaint investigations and reports.