Quality Engineer ($100K-$130K)

QUALITY ENGINEER- SMC LTD., DEVENS, MA

IMMEDIATE OPENING - APPLY ASAP

LOCATION
- Devens, MA

OVERVIEW
- Lead Quality Engineering for customer programs in molding and assembly of healthcare products. Ensure systems, documentation, inspection methods, and controls meet customer and regulatory requirements throughout product development and manufacturing.

HOURS & COMPENSATION
- Salary range: $100,000 - $130,000 per year
- Full-time, regular; exempt

KEY RESPONSIBILITIES
- Create and maintain pFMEAs, Control Plans, PPAPs, Master Validation Plans, and IQ/OQ/PQ protocols/reports
- Analyze FAIRs, process and test method validation data prior to customer submission
- Lead customer complaints and CAPA investigations
- Manage ECOs, deviations, and documentation updates
- Generate and maintain quality system documentation; manage product handling from receiving to shipping
- Assess and ensure compliance via training, auditing, and corrective/preventive actions
- Participate in customer audits and respond to observations
- Train personnel, review daily rejects, and implement corrective action plans
- Modify fixtures, inspection methods, and tools to prevent recurrence of quality issues
- Participate in design reviews, supplier/customer visits, and continuous improvement activities
- Maintain professionalism and regular attendance

BASIC QUALIFICATIONS
- Bachelor of Science degree
- 5?10 years Quality Engineering experience in healthcare/medical device industry
- Experience with ISO 13485 and 21 CFR Part 820
- Ability to read and interpret 2D part drawings
- Proficient with quality inspection equipment and SPC
- Strong problem solving, mistake-proofing, and computer skills (Word, Excel)
- Effective interpersonal, leadership, and team collaboration skills

PREFERRED QUALIFICATIONS
- New product development experience
- Experience validating large-scale automation
- Experience with 21 CFR Part 4 (Combination Products)

WHO YOU ARE
- Detail-oriented, decisive, and collaborative leader with a track record of driving quality improvements in a regulated manufacturing environment

PHYSICAL / ADA REQUIREMENTS
- Frequent bending, squatting, climbing, reaching, lifting/moving (up to 50 lbs frequently)
- Continuous walking/standing; exposure to machine shop hazards and chemicals (may require respiratory protection)
- Occasional seated keyboarding/computer work

WHY SMC LTD.
- Clean, climate-controlled environment
- Stable schedule with promotional opportunities
- Paid holidays and PTO
- Health, dental, and vision insurance; 401(k)
- Life and disability insurance; tuition reimbursement
- Training and career growth programs; Employee Assistance Program

EQUAL OPPORTUNITY
- SMC Ltd. is an equal opportunity employer (M/F/D/V) and uses E-Verify. Applicants may be subject to pre-employment screening (drug test, background check, skills assessment).

HOW TO APPLY
- Reference Requisition ID: 3931. Apply via SMC careers portal or submit application through the company?s job posting.