Impactful Quality Engineer II – Medical Devices

SMC Ltd.; Harvard (MA); On-site; USD 65,000 - 110,000; Full time

Benefits offered by this job

Clean, climate-controlled environment

Paid holiday and PTO

Health, dental, and vision insurance

401(k) retirement savings

Life and disability insurance

Promotional opportunities

Training and career growth programs

Employee Assistance Program

Job summary

SMC Ltd. seeks a Quality Engineer II to lead quality engineering activities across engineering, tooling and manufacturing for molding and assembly processes.

You will ensure robust inspection methods, controls and tools, translate customer requirements into action plans, and drive quality improvements across the plant. The role requires 5–7 years in QA/Quality Engineering in medical devices, experience with 21 CFR parts 820 and 4, and knowledge of ISO 13485.

Qualifications

• BS or AS with 5 years in Quality Engineering in medical devices
• 5-7 years’ experience in QA within drug/medical device industries
• Experience with 21 CFR Part 820 Quality System Regulation
• Experience with 21 CFR Part 4 Combination Product Regulation
• Experience with ISO 13485
• Able to read and understand 2D drawings
• Familiar with quality inspection equipment
• Excellent problem solving and mistake-proofing skills
• Computer skills: Word and Excel
• Knowledge of SPC
• Strong leadership and communication skills

Responsibilities

• Ensure raw material, packing material and finished goods testing per SOPs
• Maintain DHR and product release checklists for each lot
• Conduct inspections at in-process, in-coming and final stages
• Prepare DMR and DHR documents
• Maintain microbial records per ISO class standards
• Create master documents to track calibration and records
• Prepare control plans, FMEA and FAIR documents
• Prepare 8D and supplier CAPA reports
• Coordinate investigations, root cause analysis and corrective actions
• Review metrology equipment and drawings

Skills

Quality engineering

Problem solving

Reading drawings

Interpersonal skills

Leadership

Communication

SPC

Education

BS or AS with 5y in QA

Tools

VMS

CMM

Vernier caliper

Micrometer

Height gauge

Job description

SMC Ltd. seeks a Quality Engineer II to lead quality engineering activities across engineering, tooling and manufacturing for molding and assembly processes.

You will ensure robust inspection methods, controls and tools, translate customer requirements into action plans, and drive quality improvements across the plant. The role requires 5–7 years in QA/Quality Engineering in medical devices, experience with 21 CFR parts 820 and 4, and knowledge of ISO 13485.