We're currently working with a leading Medical Device manufacturing firm in the Twin Cities area that is looking for a skilled Quality Engineer on a contract basis. This role will focus on manufacturing quality and CAPA work.
Bachelor’s Degree in a technical discipline (e.g. EE, ME, BME, microbiology, chemistry, quality assurance), or equivalent knowledge.
Minimum of 2 years of experience in a regulatory, manufacturing or quality assurance environment. * Specific experience in complaint-handling activities.
General knowledge and application of technical and business concepts, procedures, and practices. Interprets company policies and procedures to resolve issues. Beginning knowledge of industry practices and standards.
Experience with supporting quality system procedures and policies in compliance with 21 CFR 820, CFR part 803,93/42EEC and related international reporting regulations
Experience working with quality systems, GMP requirements, ISO requirements and other applicable international requirements for complaints management
Liaise with manufacturing departments such as Engineering, R&D and QA to perform complaint and product quality investigations.
Perform hands-on investigations on complaints and products returned to the manufacturing site.
Perform Device History Record and Device Master Record reviews in response to complaint and product quality investigations.
Attend CAPA and NCR meetings to represent Market Quality.
Participate in corrective and preventative action activities.
Communicate with customers in support of complaint investigations, including but not limited to phone calls, letters, e-mails and site visits.
Perform trending on complaints and product quality issues associated with devices manufactured at the specific OSTA site. * Perform complaint handling related duties, including but not limited to, complaint creation, evaluation, investigation and closure.
Perform all other duties as required.analysis of data requires evaluation of identifiable factors. Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
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