We're looking for a Quality Engineer, working in the Biotechnology/Medical Devices industry in Minneapolis, Minnesota, United States.
Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determines the responsibility for products or materials that do not meet required standards and specifications.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
Leads/Participates in operations quality activities for EU MDR (Medical Device Regulation) remediation.
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
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 and minimum of 2 years of experience in Medical Device or other highly regulated industry, or advanced degree with 0 years of experience.
Ability to understand and apply standards to perform gap analysis and ensure compliance.
Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
Familiarity with Regulatory Standards.
We're offering Competitive Compensation and Benefits. This position may present an opportunity to go permanent.
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.