We're looking for a Quality Engineer, working in the Biotechnology/Medical Devices industry in Minneapolis, Minnesota, United States.
• Execute and participate in FMEA/Risk Management activities.
• Serves as a technical resource for problem investigations to guide root cause analysis and corrective action development.
• Contribute to the completion of specific programs and projects.
• Anticipate roadblocks; provide direction for navigating the quality system and supporting applications.
We are offering Competitive Compensation and Benefits. This position may present an opportunity to go permanent.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
• Bachelors degree in Engineering or technical discipline
• 2+ years quality, reliability, or design assurance engineering experience SPECIALIZED KNOWLEDGE REQUIRED
• Working knowledge of Statistical Analysis tools: DOE, Gage R&R, Confidence and Tolerance intervals, ANOVA, Capability, Hypothesis testing
• Experience executing risk management activities, including Risk Management planning, risk analysis techniques such as Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA), and hazard analysis
• Knowledge of applicable ISO standards and FDA regulations
• GMP, QSR, ISO 13485, ISO 14971 experience • Basic PC skills (MS Word, Excel, PowerPoint, MS Project, etc.)
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.