Job Description

The incumbent applies systems engineering and quality assurance principles and techniques to the product development lifecycles. The position will focus heavily on complaint processing activities. The position may also perform system testing for Client medical devices and other business systems that support the Quality System.


Responsibilities

- Investigate and process medical device complaints and maintain open complaint level to acceptable levels.

- Assist in maintaining quality system information databases as assigned. Evaluate quality data and prepare periodic reports to monitor trends.

- Assist in supporting manufacturing in the investigation of manufacturing problems and product complaints to determine the root cause and recommend appropriate corrective and preventive action to prevent recurrence.

- Process non-conforming material reports including MRB dispositioning.

- Assist in developing and establishing quality systems programs and plans that ensure compliance with the Quality System Regulations.

- Develop, implement, and/or maintain instructions/methods for inspecting, testing and evaluating product conformance to specification.

- Support Engineering in the development, testing, verification, validation and commercialization of new products.

Education + Experience

- B.S. in Engineering Related Field

- 3+ years related quality assurance, quality engineering experience or an equivalent combination of experience and education. Medical device experience preferred.

- Experience investigating and processing medical device product complaints

- ASQ certification a plus.

- Intermediate knowledge of FDA Quality System Regulation 21 CFR Part 820.

- Good organizational, attention to detail and follow-through skills

- Excellent verbal and written communication skills

- Ability to interface with multiple groups in the organization.

- Systems - Basic computer skills - word processing, spreadsheet, windows. MS Office preferred.

- Willingness to contribute to other departments as necessary.

Other Benefits

Job Summary

  • Published on: 2020-10-29 06:08:57
  • Vacancy: 08
  • Employment Status: Contract
  • Experience: 3 Year
  • Job Location: Lawrence, MA
  • Salary: $26 - 36 per hour k
  • Gender: Any
  • Application Deadline: 2020-11-17

About the Company

  • Company Name: .
  • Address: Lawrence, MA
  • Website:
  • Company Profile:

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