Senior Quality Engineer II, Medical Devices

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

Benefits offered by this job

Health insurance

Paid time off

401(k)

Life insurance

Disability insurance

Career growth

Training programs

EAP

Job summary

SMC Ltd. is seeking a Quality Engineer II to oversee quality engineering across molding and assembly operations.

You will work with engineering, tooling, and manufacturing to ensure proper systems, inspection methods, and tools are used to verify product quality throughout the process. The role requires strong analytical and leadership skills, experience with ISO 13485 and 21 CFR 820, and hands-on proficiency with metrology tools.

Qualifications

• Bachelor's or Associate's degree with 5+ years in quality engineering in medical devices/drug spaces.
• 5+ years of experience in Quality Engineering within medical device/drug industries.
• Experience with 21 CFR Part 820, 21 CFR Part 4, and ISO 13485.
• Ability to read and interpret 2D drawings and use quality inspection equipment.
• Strong problem solving and mistake-proofing skills.

Responsibilities

• Ensure raw/materials and finished goods testing per SOPs.
• Maintain DHR and product release checklists for each lot.
• Conduct in-process, in-coming, and final inspections.
• Prepare DMR, DHR, and other quality documents.
• Lead calibration records and control documents.
• Create control plans, FMEA, and FAIR docs.
• Prepare 8D and supplier CAPA reports.
• Coordinate investigations and root-cause analyses.

Education

Bachelor of Science Degree or Associate's degree

Problem solving

Reading 2D drawings

Quality tools & inspection

Interpersonal skills

Tools

VMS

CMM programming

Vernier caliper

Micrometer

Height gauge

Job description

SMC Ltd. is seeking a Quality Engineer II to oversee quality engineering across molding and assembly operations.

You will work with engineering, tooling, and manufacturing to ensure proper systems, inspection methods, and tools are used to verify product quality throughout the process. The role requires strong analytical and leadership skills, experience with ISO 13485 and 21 CFR 820, and hands-on proficiency with metrology tools.