Quality Engineer

Quality Engineer (Medical Device / Plastics Manufacturing)

Pay: $85,000 – $100,000 per year

We’re looking for a passionate Quality Engineer to join our team and help us drive excellence across product development and manufacturing. In this dynamic role, you’ll take the lead on key initiatives such as part validation, qualification, and support for sustaining programs. You’ll also be the go‑to expert for addressing customer quality concerns—collaborating closely with both production and engineering teams to find solutions and ensure we deliver the highest standards every time.

• Participates in the organization’s overall Stage‑Gate approach to product realization. Has Responsibility for APQP and PPAP activities for new and changed programs as directed by the Quality & Regulatory Manager.
• Carries out Quality Planning:
  Process Flow Diagrams, Process FMEA, and Process Control Plan. Prepare work instructions and Inspection instructions.
• PPAP / validation for purchased materials and components.
• Pre‑Launch / early containment activity implementation and reports.
• Continually improve relationships and the company’s position with customers and suppliers through direct interface and strong leadership.
• Responsibility for making disposition on material placed on‑hold internally.
• Participates in the creation and management of CAPAs, SCARs, RMA activities, and sustaining programs.
• Writes and issues Quality Alerts.
• Write and perform validation protocol.
• Works collaboratively with customers and employees to provide consultation and advise on quality issues.
• Serves as primary contact for quality issues for assigned customers as based upon direction by the Quality Assurance Manager. May be required to visit customer locations as needed.
• Conducts training as requested and/or needed pertaining to the Quality Management System.

• B.S. Degree or equivalent work experience is required.
• Valid identification and the ability to legally work in the United States.
• 4 years’ experience in a regulated manufacturing environment.
• APQP, PPAP, IQ.OQ.PQ., SPC experience preferred.
• ISO
  9001, ISO
  13485 or FDA experience preferred.
• Epicor or similar ERP experience preferred.
• Experience in print reading, cGMP/GDP, GD&T, and cosmetic specifications preferred.
• Ability to manage multiple projects concurrently.
• Excellent verbal and written communication skills with experience in Microsoft Suite.
• Experience with change control, revision change and documentation.
• Ability to manage time effectively while handling multiple projects and responsibilities.

• Associate

• Full‑time

• Quality Assurance, Engineering, and Manufacturing

• Manufacturing, Medical Equipment Manufacturing, and Plastics Manufacturing

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