Supplier Quality Engineer, Plastics (Onsite - Acton, MA) (Medical Devices)

Location: On-site at the Acton, Massachusetts office/plant/lab; approximately 25% travel

Annual base salary: $70,400–$105,650, with potential incentive compensation.

Company

hirify.global is a medical device company developing the Omnipod wearable insulin delivery platform and related drug delivery technologies.

What you will do

• Deliver supplier quality engineering activities for the Plastics category, supporting sourcing strategies and continuity of production.
• Apply injection molding, mold tool design, material selection, design for manufacturability, cosmetic criteria, and process qualification expertise.
• Develop KPIs, supplier quality metrics, dashboards, and risk management strategies.
• Lead sustaining projects involving cost reduction, capacity increases, dual sourcing, and risk mitigation.
• Partner with suppliers, sub-tier suppliers, supply chain, engineering, operations, procurement, and regulatory teams to improve performance.
• Lead audits, supplier change reviews, root cause analyses, SCAR corrective actions, PPAP, and supplier improvement activities.

Requirements

• Bachelor’s degree in Mechanical Engineering, Industrial Engineering, or a related field.
• 1–3 years of experience in medical device supplier quality, quality, manufacturing, or engineering.
• Strong understanding of QMS, complaint handling, 21 CFR Part 820, and Part 11 requirements.
• Experience with supplier selection, PPAP, DOE, process capability analysis, Gage R&R, control plans, SPC, inspection procedures, and supplier audits.
• Ability to analyze quality data and generate actionable insights through dashboards and reports.
• Strong communication, organization, problem-solving, prioritization, and cross-functional collaboration skills.

Nice to have

• Experience with plastics manufacturing or materials.
• Prior co-op or internship experience.

Culture & Benefits

• Full-time employment in a team-oriented, fast-paced environment.
• Medical, dental, and vision insurance.
• 401(k) with company match.
• Paid time off and employee wellness programs.
• Opportunity to contribute to a global medical device product platform.