Search Jobs

Connecting expertise with opportunity.

Design Quality Engineer

Tewskbury , MA

Posted: 02/07/2024 Industry: Engineering and Technical Job Number: 16424

Job Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services while treating candidates with the professionalism and respect they deserve.

Title: Design Quality Engineer
Hiring Organization: Connexion Systems & Engineering

  • Duration:  PERM
  • Pay rate: $110-130k
  • Job Location: Tewksbury, MA
  • Job# 16424

  • Responsible for the overall health of design control process. Responsible for assuring NPI and sustaining projects meet customer expectations, and regulatory requirements.
  • Partner with Development and Engineering departments and ensure that design control requirements are being met in an effective manner in order to achieve quality by design, including those for design verification, validation, specification and procedure development, risk management, and design review
  • Provides input to design and manufacturing engineering project DHF deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested. Review DHF files for accuracy and completeness and provide guidance on FDA compliance and procedures.
  • Review and approve design control related Change Notices (CNs) within the documentation system as applicable.
  • Create processes and process improvements to ensure consistent implementation of internal requirements and external regulations and standards.
  • Represent the design quality functions for the review and approval of designated design outputs.
  • Act as a subject matter expert on design control process and Quality Engineering. The Quality Engineering subjects are Risk Management, Test Method Validation (TMV), Statistics, Reliability Engineering, Process Validation (PV).
  • Support the quality management system as required.
  • BS in Engineering with 8 years of related experience or equivalent combination of education and experience.
  • Medical device development control experience required.
  • Working knowledge of Software development lifecycle desired.
  • Working knowledge and practical application of 21 CFR Part 820, ISO 13485, ISO 14971.
  • Practical knowledge and experience using Minitab or other statistical analysis tools.
  • Understanding and application of Gage R&R and Measurement System Analysis desired
  • Process validation experience including IQ/OQ/PQ desired.
  • Ability to communicate ideas and information clearly, effectively and concisely.
  • Highly detail oriented with strong organization and prioritization skills.
  • BS in Engineering or other technical discipline 

  • Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
    When responding to this job posting you MUST include the Job# and Job Title in your subject line.
    If you are active in a job search but this job is not for you, please reach out to . We would be glad to help you find the perfect job!

Meet Your Recruiter

Jim Hunt
Sr. Technical Recruiting Manager

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.