Are you experienced in investigating product complaints? Do you have prior experience in Medical Devices? THE RIGHT STAFF is currently seeking a Manufacturing Quality Engineer to support a market quality team for a Medical Device company in Brooklyn Park. This role will be assisting in complaint investigations, communicating event descriptions, and working with manufacturing departments to document and close complaints. Ideal candidates will have 2+ years of experience with regulatory, manufacturing or quality assurance environment, and 2+ years of complaint investigations.
RESPONSIBILITIES OF THE MANUFACTURING QUALITY ENGINEER:
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 client 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
REQUIREMENTS OF THE MANUFACTURING QUALITY ENGINEER:
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 and 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.
Strong verbal and written communication skills.
Strong analytical, organizational, communication and interpersonal skills.
Strong computer skills; working knowledge of MS Office applications.
Temp to Hire
Work From Flexibility
THE RIGHT STAFF offers Healthcare, Holiday Pay and Vacaion Bonus!
Apply by sending a resume to firstname.lastname@example.org or call 952-546-1100 for more details.
Applicants selected for this position with our client will be required to complete a background check. Successful completion of this assessment is required for further consideration.
THE RIGHT STAFF wants to help you succeed! Our team of seasoned professionals works to match you to the best job, best fit, and best location. Contract assignments to full-time permanent positions, we are here to assist you!
THE RIGHT STAFF is an Equal Opportunity Employer.