Apply now and our proprietary system will quickly have you in front of a live recruiter.
The Opportunity
Description
We're looking for a Quality Engineer , working in Biotechnology/Medical Devices industry in 7611 Northland Drive North, Minneapolis, Minnesota, 55428, United States .
Responsibilities:

• 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.

Our Client
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
Education required:

• 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.)

Desired qualifications:

• Master's degree
• 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?