Sr. Quality Engineer

Job Description:

The Senior 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 Senior 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 requirements as required by ConforMIS and/or customer specifications. He/She 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
  • Champion quality engineering process improvements within ConforMIS manufacturing cells.
  • Review and resolve challenging quality engineering issues emanating from NCMR, CAPA, Complaint, Risk Management, etc.
  • Apply expertise and discipline to drive quality engineering change in the organization.
  • 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. Ensure that the processes for design transfer consistently meets expected short term and long term capability requirements
  • 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.
  • Develop, review, and maintain metrics.
  • Perform and/or participate in quality audits.
  • Develop and maintain strong, internal working relationships across ConforMIS.
  • Understand the objectives, responsibilities, and mission of the Quality department and works towards those goals.
  • Prioritize and plan work activities; adapt for changing conditions.
  • Other responsibilities as assigned.

Qualifications:

  • BS (MS preferred) Degree in engineering (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:

•    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.
•    Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
•    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.

Additional Skills, Abilities, Competencies Preferred:
•    GD&T
•    SPC
•    KAIZEN
•    Failure Modes Effect Analysis (FMEA)
•    LEAN
•    Root cause analysis
•    Six sigma
•    CAD

ConforMIS is an Equal Opportunity Employer

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