Quality Engineer

Job Title: Quality Engineer Job Description

We are seeking a passionate Quality Engineer to join our team and help drive excellence across product development and manufacturing. In this dynamic role, you will lead key initiatives such as part validation, qualification, and support for sustaining programs. You will also be the expert addressing customer quality concerns by collaborating closely with both production and engineering teams to ensure we deliver the highest standards every time.

Responsibilities

• Participate in the organization's overall Stage-Gate approach to product realization.

• Manage APQP and PPAP activities for new and modified programs as directed by the Quality & Regulatory Manager.

• Carry out Quality Planning including Process Flow Diagrams, Process FMEA, and Process Control Plan.

• Prepare work instructions and Inspection instructions.

• Oversee PPAP/validation for purchased materials and components.

• Implement pre-launch/early containment activities and generate reports.

• Improve relationships and the company's position with customers and suppliers through direct interface and strong leadership.

• Make disposition decisions on material placed on-hold internally.

• Participate in the creation and management of CAPAs, SCARs, RMA activities, and sustaining programs.

• Write and issue Quality Alerts, and perform validation protocols.

• Collaborate with customers and employees to provide consultation and advice on quality issues.

• Serve as the primary contact for quality issues for assigned customers as directed by the Quality Assurance Manager.

• Conduct training related to the Quality Management System as requested or needed.

Essential Skills

• Bachelor's Degree or equivalent work experience required.

• 4 years of experience in a regulated manufacturing environment.

• Experience in APQP, PPAP, and SPC preferred.

• Familiarity with ISO9001, ISO13485, or FDA standards preferred.

• Experience with Epicor or similar ERP systems preferred.

• Proficiency in print reading, cGMP/GDP, GD&T, and understanding cosmetic specifications preferred.

• Ability to manage multiple projects concurrently.

• Excellent verbal and written communication skills with proficiency in Microsoft Suite.

• Experience with change control, revision change, and documentation management.

Additional Skills & Qualifications

• Medical device and injection molding experience preferred.

• Plastics injection molding knowledge advantageous.

Work Environment

This position involves desk work, time in the Quality Engineering lab, and interaction on the production floor. Our work environment offers good benefits and is situated on a large site with nice amenities.

Job Type & Location

This is a Permanent position based out of Saint Paul, Minnesota.

Job Type & Location

This is a Permanent position based out of Saint Paul, MN.

Pay and Benefits

The pay range for this position is $85000.00 - $100000.00/yr.

MedicalDentalVision401k with employer matchSTD/LTDPet InsuranceTuition ReimbursementGym Reimbursement3 Weeks Accrued PTO, 9 paid Holidays

Workplace Type

This is a fully onsite position in Saint Paul,MN.

Application Deadline

This position is anticipated to close on Dec 5, 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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.