Sustaining Quality Engineer II

SMC Ltd; Harvard (MA); Sur place; USD 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Climate-Controlled environment

Stable schedule

Health, dental, and vision insurance

401(k) retirement savings

Life and disability insurance

Tuition reimbursement

Training and career growth programs

Employee Assistance Program

Résumé du poste

SMC Ltd. is seeking a Quality Engineer II to lead quality engineering activities across molding and assembly in our US operation. You will ensure robust inspection methods, documentation, and compliance with ISO 13485 and 9001 standards.

In this role you will work closely with engineering, tooling and manufacturing to implement control plans, CAPA, and DHR/DMR processes, driving continuous improvement and supplier quality initiatives.

Qualifications

• Bachelor of Science or Associate degree with required QA experience.
• 5+ years in quality engineering within medical device/drug sectors.
• Experience with 21 CFR Part 820 and ISO 13485 essential.
• Ability to read 2D drawings and operate inspection equipment.
• Strong problem solving and documentation skills.

Responsabilités

• Ensure raw material, in-process and final inspections per SOPs.
• Maintain DHR/DMR and product release checklists for lots.
• Prepare control plans, FMEA, FAIR, CAPA reports.
• Coordinate root cause analysis and corrective actions.
• Perform metrology activities and drawing reviews.
• Support IQ/OQ/PQ validation and supplier quality initiatives.

Connaissances

Quality engineering

Troubleshooting

Communication

Measurement methods

Formation

Bachelor's or Associate degree

Outils

VMS

CMM programming

Measurement tools

Description du poste

SMC Ltd. is seeking a Quality Engineer II to lead quality engineering activities across molding and assembly in our US operation. You will ensure robust inspection methods, documentation, and compliance with ISO 13485 and 9001 standards.

In this role you will work closely with engineering, tooling and manufacturing to implement control plans, CAPA, and DHR/DMR processes, driving continuous improvement and supplier quality initiatives.