We are looking for a Quality Engineer, working in the Biotechnology/Medical Devices industry in Minneapolis, Minnesota, United States.
Executes and participates in FMEA/Risk Management activities.
Serves as a technical resource for problem investigations to guide root cause analysis and corrective action development.
Works in a cross-functional, collaborative, team-based environment
Works under minimal supervision. Independently determines and develops approach to solutions.
Contributes to the completion of specific programs and projects.
Anticipates roadblocks; provides direction for navigating the quality system and supporting applications.
The pay range we are offering is 35 to 40 per hour. 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
Years of experience:
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
Ability to effectively manage multiple competing priorities
Strong written and verbal communication skills
Good interpersonal and group leadership skills
Basic PC skills (MS Word, Excel, PowerPoint, MS Project, etc.)
5+ years medical device or other regulated industry experience
Experience with medical devices, in particular cardiac surgery devices
Experience with reliability testing and analysis of medical devices
Understanding of clinical/technical applications of cardiovascular products and human anatomy
Certified Quality Engineer (CQE)
Certified Reliability Engineer (CRE)
Experience with ISO 5840, IEC 62366
Effective negotiation, collaboration and influencing skills
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.