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Job Title: Quality EngineerJob Description

Support the Quality Management System (QMS) organization by collaborating with design and manufacturing teams to complete operations quality activities. This role involves applying quality engineering concepts such as design control, process control, risk management, supplier quality, root cause analysis, statistical analysis, and continuous improvement activities. Ensure design and product performance requirements are met in compliance with regulatory, customer, and internal standards. Skills in verification testing and sterilization validation are desired. Engage in routine activities such as First Article Inspections (FAI), CAPA, NCMR, change order review, and training.

Responsibilities

+ Function as the operation’s quality representative during engineering project execution.

+ Ensure product development projects and changes to existing products comply with Quality System Regulations.

+ Conduct NCMR and CAPA investigations and reports, assist in troubleshooting manufacturing problems, and ensure requirement compliance.

+ Collaborate with suppliers on NCMRs and supplier CAPAs.

+ Participate in cross-functional teams for reviewing and disposing of nonconforming products or components.

+ Develop and assist in maintaining Product Risk Management Files, including Risk Management Plans, Risk Assessments, DFMEA, PFMEA, and Risk Management Reports.

+ Prepare and review documentation with accuracy, completeness, and effectiveness.

+ Participate in the development of Design Verification and Validation test plans/protocols and Process Verification and Validation test plans/protocols.

+ Provide guidance on Product Requirements compliance and direction for sample size and statistical analysis of Verification and Validation testing.

+ Participate in Design Reviews and FMEA Reviews.

+ Participate in complaint investigations and ensure thorough documentation.

+ Provide direction to project teams on Quality Policies/Procedures, including verification, validation, statistical methods, and design controls.

+ Assist in training for Special Work Orders, Receiving Inspection Processes, and FAIs as required.

Essential Skills

+ 5+ years' experience in Quality Management System (design/manufacturing).

+ Expertise in NCMR's and CAPA's investigation.

+ Working knowledge of medical device regulations (FDA 21CFR820, ISO).

+ Experience in process control, risk management, supplier quality, and supplier quality assurance.

+ Skills in root cause analysis and continuous improvement.

+ Proficiency in verification software, test automation, and automated testing.

+ Experience in sterilization validation and failure analysis testing.

+ Ability to organize and prioritize workflow across multiple projects.

+ Knowledge of manufacturing operations, process verification and validation, and geometric design and tolerance (GD&T).

Additional Skills & Qualifications

+ Requires a B.S. degree in Science, Engineering, Technology, or associated fields.

+ 5+ years’ experience in the medical device industry.

+ Working knowledge of new product design and development in medical devices.

+ Application of risk management, including PFMEA.

+ Excellent organizational and interpersonal skills for working in cross-functional teams.

+ Ability to read and understand prints and specifications.

Work Environment

This role is situated in an amazing new facility equipped with state-of-the-art technology and ample space for idea development. The environment promotes high communication levels and values input from all team members. There is a family-first team mindset, and flexibility in scheduling is offered. The company is experiencing significant growth and has numerous purchase orders, ensuring a thriving work atmosphere with opportunities for personal and professional development.

Pay and Benefits

The pay range for this position is $38.00 - $48.00/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 Brooklyn Park,MN.

Application Deadline

This position is anticipated to close on May 30, 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.