Quality Engineer II - Medical Devices: Quality & Process Excellence

SMC Ltd; Harvard (MA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

401(k) retirement savings

Life and disability insurance

Training and career growth programs

Tuition reimbursement

Employee Assistance Program

Job summary

SMC Ltd. is seeking a Quality Engineer II to lead quality engineering activities across molding and assembly, ensuring proper controls, inspection methods, and quality tools are used throughout our plants.

You will interpret customer requirements, implement action plans, and procure equipment/tools needed to perform tasks, while maintaining DHR, CAPA, and control plans to assure product conformity.

Qualifications

• Bachelor or Associate degree with relevant QA experience in medical devices.
• 5–7 years of quality engineering experience in drug/medical device industries.
• Experience with 21 CFR Part 820 and Part 4 Regulation.
• Experience with ISO 13485 and document control processes.
• Ability to read 2D drawings and inspect with standard QA equipment.
• Strong problem solving, leadership, and communication skills.
• Proficient with MS Word/Excel and SPC knowledge.

Responsibilities

• Ensure raw material, packing material, and finished goods testing per SOPs.
• Maintain device history records and product release checklists.
• Conduct inspections at in-process, in-coming, and final stages.
• Prepare DMR, DHR, and control plans for products.
• Coordinate calibration and document control activities.
• Lead 8D and supplier CAPA reports and root-cause analysis.
• Oversee metrology activities and drawing reviews.
• Implement IQ/OQ/PQ validation for processes and equipment.
• Ensure compliance with ISO 13485 and ISO 9001 standards.

Skills

Quality engineering

Metrology

Problem solving

Reading 2D drawings

Regulatory knowledge

Leadership

CP/Microsoft Office

SPC knowledge

Education

Bachelor of Science Degree

Associate's degree with 5 years experience

Tools

VMS

CMM programming

Vernier caliper

Micrometer

Height gauge

Job description

SMC Ltd. is seeking a Quality Engineer II to lead quality engineering activities across molding and assembly, ensuring proper controls, inspection methods, and quality tools are used throughout our plants.

You will interpret customer requirements, implement action plans, and procure equipment/tools needed to perform tasks, while maintaining DHR, CAPA, and control plans to assure product conformity.