• Quality Engineer

    Actalent (Brooklyn Park, MN)


    Summary:

    The Design Quality Engineer leads design control efforts to develop new and improve existing medical devices. Works closely with various functions, including R&D and Product Development core teams to ensure appropriate design controls are established and achievable. Also supports process development, manufacturing related design changes, maintaining regulatory compliance, manufacturability improvements, and cost reduction efforts.

    Essential Duties and Responsibilities (but not limited to):

    + Own creation and implementation of Quality Engineering Design Control deliverables

    + Mentor and assist DQE's in the creation and implementation of Quality Engineering Design Control deliverables; Mentor and coach Design Quality Engineering Technicians

    + Supervise interns

    + Creates and drives content of Quality Engineering Design Control deliverables

    + Assist design function with the creation of User Requirements and ensure they are discrete, objective, measurable, verifiable, and traceable into Product Specifications; create product trace matrix

    + Assist and help drive the design function in the creation of accurate and repeatable test and inspection methods

    + Actively participate in core team and customer facing meetings; present information as needed

    + Drive and oversee all risk management activities throughout the device life cycle

    + Drive accurate and repeatable Test Method and Inspection methods development, Lead Test Method and Inspection method validation; analyze data and prepare test reports

    + Create NCMRs as required, drive the resolution of NCMRs, drive root cause analysis for NCMRs related to product development; Track NCMR for project and report as required, Manage related CAPA, Communicate CAPA related information to customer as appropriate

    + Create Quality Plan based on project needs and drive Quality Plan activities, ensure alignment with customer

    + Expertise in 21 CFR 820 and ISO 13485 regulations, assists in aligning processes with regulations

    + Oversee and approve document change requests, deviations, and special work order processes

    + Review and approve equipment specification and qualification activities; Ensure component specifications are properly defined and evaluated through the creation of supplied component sampling plan

    + Support on-time Design Verification and Design Validation and as needed Process Validation IQ/OQ/PQ/PPQ planning & execution; Support manufacturing lines by resolving components issues or other manufacturing barriers in a timely manner

    + Drive creation and execution of biocompatibility and sterilization qualifications

    + Oversee content of the Design History File, its completeness and integrity; Audit Design History File for completeness

    + Drive supplier management activities including identification of appropriate suppliers, assisting with supplier qualification, assisting with supplier audits, assisting in resolution of supplier issues, and participating in and supplier process qualifications

    + Support external audit and certification efforts conducted by customers and regulatory bodies

    + Support Design Quality metrics in alignment with company goals

    + Support and fill in on other projects as needed

    Education/Experience/Skills:

    + Bachelor’s Degree in Stem Field

    + Higher Level Degrees, such as MBA preferred

    + 5 -7 years quality, 5 years design experience

    Desirable qualifications below:

    + Demonstrated use of quality tools and methodologies

    + Strong problem solving proficiency

    + Ability to manage and prioritize multiple tasks and remain focused on personal objectives

    + High attention to detail and accuracy

    + Proven ability to work effectively independently and on a multi-disciplinary team

    + Good understanding of ISO 13485 and FDA QSR

    + ISO 13485 Lead Auditor training and certification

     

    Job Type & Location

     

    This is a Permanent position based out of Brooklyn Park, MN.

    Pay and Benefits

    The pay range for this position is $100000.00 - $110000.00/yr.

     

    Standard Benefits, 401K platform, and three weeks PTO

     

    Workplace Type

     

    This is a fully onsite position in Brooklyn Park,MN.

     

    Application Deadline

     

    This position is anticipated to close on Dec 18, 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.