Manufacturing Engineer I

1970-01-01Davis Companies Donald J. Lynch Boulevard, Suite 201MarlboroughMA01752USAcustomer support[+800-482-9494][+508-481-8519]
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Manufacturing Engineer I

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Manufacturing Engineer I

Job Title: Manufacturing/ Market Quality Engineer As a Manufacturing/ Market Quality Engineer working on the Market Quality team, you will be empowered and inspired to do your best work. You will contribute to our mission by assisting in the complaint investigation, communicate and follow-up on event of description and work closely with manufacturing departments and customers to promote quality improvements. In a typical day, you will work on complaint investigation via investigation of the products, communicate with the manufacturing departments e.i. Quality Assurance, Manufacturing, Design Assurance, and R&D and document and close of complaints.

(To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the, education, knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

  • Bachelor’s Degree in a technical discipline (e.g. EE, ME, BME, microbiology, chemistry, quality assurance), or equivalent knowledge.
  • Minimum of 1-2 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. PREFERRED QUALIFICATIONS:
  • 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.



  • 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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  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
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