Quality Engineer II: Medical Device Sustaining

Nashoba Valley Chamber of Commerce; Massachusetts; On-site; USD 65,000 - 110,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

401(k) retirement savings

Paid holiday and PTO

Life and disability insurance

Promotional opportunities

Training and career growth programs

Employee Assistance Program

Job summary

SMC Ltd. is seeking a Quality Engineer II to oversee quality engineering across molding and assembly. You will ensure systems, inspection methods, and tools meet customer requirements and regulatory standards.

You’ll lead action plans, acquire needed equipment, and verify product quality at all process stages. The role requires strong problem solving, leadership, and knowledge of ISO 13485 and CFR guidelines.

Qualifications

• Bachelor of Science or Associate degree with 5 years of experience in quality engineering.
• 5-7 years’ experience in quality engineering within drug/medical device industries.
• Experience with 21 CFR Part 820, Part 4, and ISO 13485.
• Ability to read and understand 2D drawings.
• Proficiency with quality inspection equipment and control plans.

Responsibilities

• Ensure raw material, packing material, 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 and DHR documentation.
• Maintain microbial records per ISO class-7/8 procedures.
• Create control plans, FMEA, and FAIR documents.
• Coordinate calibration and document control activities.
• Lead 8D and supplier CAPA investigations.

Skills

Quality engineering

Problem solving

Interpersonal skills

Leadership

Analytical thinking

Documentation

Education

Bachelor or Associate in engineering

Tools

Word

Excel

CMM programming

SPC

Job description

SMC Ltd. is seeking a Quality Engineer II to oversee quality engineering across molding and assembly. You will ensure systems, inspection methods, and tools meet customer requirements and regulatory standards.

You’ll lead action plans, acquire needed equipment, and verify product quality at all process stages. The role requires strong problem solving, leadership, and knowledge of ISO 13485 and CFR guidelines.