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Senior Quality Engineer

Company: Conformis
Location: Billerica
Posted on: August 7, 2022

Job Description:

Job Summary:The Sr. Quality Engineer is responsible for performing quality engineering activities applicable to design, development, and manufacturing of orthopedic implants and instruments. This includes interpretation and implementation of quality standards for product development and routine manufacturing activities. The Sr. Quality Engineer applies quality engineering principles to address product and process issues, ensure reliable new and/or changed product development, lead investigations, and provide general support of the quality system. The Sr. Quality Engineer ensures that the processes for design controls meet specifications as required by Conformis and/or customer specifications. They will work on a wide range of quality problems related to Quality Systems and Product Quality.
Essential Duties and Responsibilities:

  • Work collaboratively with R&D, Quality, and Manufacturing Engineering teams to develop and deploy harmonized design controls and quality engineering fundamentals
  • Review and resolve challenging quality engineering issues emanating from NCMR, CAPA, Complaint, Risk Management, etc.
  • Lead and/or support development and implementation of procedures for measurement system analysis, Test Method Validation, GR&R
  • Support FMEA, dFMEA, Control Plans, Cost of Quality, DfM activities to assure that designed product and processes perform to specifications.
  • Ensure that principles of Design Control are applied to Product and Process Changes and New Product Development.
  • Provide feedback to design processes to improve quality and reliability.
  • Review in-process data from manufacturing processes and facilitate corrective and preventive actions as appropriate.
  • Participate in creation, review, and approval of protocols and reports for process and product validations.
  • Interface with design engineering and production to implement product design changes and to introduce new products to manufacturing.
  • Create and/or review technical documentation, including project plans, test procedures, and design documents.
  • Perform and/or participate in quality audits, as required
  • Develop and maintain strong internal working relationships across Conformis.
  • Prioritize and plan work activities; adapt for changing conditions.
  • Other responsibilities as assigned.
    Qualifications:
    • BS (MS preferred) Degree in engineering (BME/ME/EE/IE) or a scientific field.
    • 3-5 years' experience in quality engineering and/or a manufacturing engineering/industrial engineering environment with at least 2 years in regulated industry
    • Certified Quality Engineer (or equivalent) preferred Skills, Abilities, Competencies Required:
      • Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
      • Demonstrated applied knowledge of FDA and international medical device regulations
      • Strong understanding of statistics and its application in an engineering environment
      • Computer proficiency with MS Office Suite. Experience with Minitab desirable.
      • Strong work ethic and positive team attitude.
      • Ability to recognize and prioritize quality issues
      • Excellent written and verbal communication skills.
      • Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness.
      • Strong organizational, analytical, and time-management skills.
      • Able to self-motivate and work both independently and as part of a cross-functional team.
      • Ability to travel regularly between Conformis facilities in Billerica, MA and Wilmington, MA.
      • Knowledge and familiarity with GD&T, SPC, KAIZEN, Failure Modes Effect Analysis (FMEA), LEAN, root cause analysis, Six Sigma, and CAD.
        Conformis is an Equal Opportunity Employer

Keywords: Conformis, Billerica , Senior Quality Engineer, Engineering , Billerica, Massachusetts

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