• Principal Quality Engineer

    Actalent (Waltham, MA)


    Responsibilities:

    + Represent the Quality Department as a subject matter expert in Incoming Inspection/Supplier Quality within a cross-functional team for new product development of medical devices.

    + Develop and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of components, materials, products, and production equipment.

    + Develop test plans, inspect, and assess material compliance based on dimensional and attribute acceptance criteria, while documenting and communicating inspection results.

    + Determine optimal measurement devices to perform inspections and understand AQL tables to select the correct sampling rate based on quality criteria.

    + Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing.

    + Utilize quality tools including Risk analysis FMEA, statistical techniques such as six-sigma and DOE (design of experiments), root cause analysis, and reading and correcting drawings.

    + Lead the development and implementation of visual and physical inspections of injection molded, mechanical, electrical, and packaging components to ensure they meet specifications.

    + Assist Quality Engineers and manufacturing personnel with calibration activities, including reviewing and retrieving calibrated equipment necessary for processing.

    + Manage Root Cause Analysis activities stemming from MRB, RMA, and CAPA.

    + Analyze and trend non-conformances through NCMRs and RMAs.

    + Assist in supplier audits and visits, as required.

    + Assist in the manufacturing transfer process, including the creation and completion of planning documentation, DMR/DHR, and validation protocols (IQ, OQ, PQ).

    + Support other duties as assigned by the manager.

    Required Knowledge/Skills, Education, and Experience:

    + Bachelor’s degree in Engineering, Biomedical Engineering, or Life Sciences.

    + Minimum of 10 years of experience as a Quality or Design Quality Engineer in the medical device industry supporting the development of complex electro-mechanical devices.

    + Experience with new product development.

    + Working knowledge of QSR, MDD/MDR, ISO-13485, and ISO-14971.

    + Experience in metrology.

    + Strong organizational skills, detail-oriented, and the ability to meet changing deadlines in a fast-moving environment.

    + Strong documentation capability for protocol and report generation and review.

    + Ability to communicate effectively within a technical environment.

    + Team player who celebrates winning together.

    Pay and Benefits

    The pay range for this position is $70.00 - $110.00/hr.

     

    Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave)

     

    Workplace Type

     

    This is a fully onsite position in Waltham,MA.

     

    Application Deadline

     

    This position is anticipated to close on May 26, 2025.

    About Actalent

    Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

     

    The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

     

    If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.