Quality Engineer II
Posted on: August 2, 2022
Job Summary:The Quality Engineer II 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 Quality Engineer II 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 Quality Engineer
II 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
- 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,
- Support FMEA, dFMEA, Control Plans, Cost of Quality, DfM
activities to assure that designed product and processes perform to
- 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
- 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
- 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
- Prioritize and plan work activities; adapt for changing
- Other responsibilities as assigned.Qualifications:
- BS (MS preferred) Degree in engineering (BME/ME/EE/IE) or a
- 2-5 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) preferredSkills,
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
- Strong understanding of statistics and its application in an
- Computer proficiency with MS Office Suite. Experience with
- 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
- 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 , Quality Engineer II, Engineering , Billerica, Massachusetts
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