Quality Engineer II: Sustaining & Process Improvement

SMC Ltd.; Harvard (MA); In loco; USD 65.000 - 110.000; Tempo pieno

Vantaggi offerti da questo lavoro

Clean environment

Paid holidays

Health insurance

401(k) plan

Life and disability insurance

Promotional opportunities

Training programs

Employee Assistance Program

Descrizione del lavoro

SMC Ltd. in Massachusetts is seeking a Quality Engineer II for sustaining projects. You will collaborate with engineering, tooling, and manufacturing to ensure robust quality systems, inspection methods, and tools across molding and assembly processes.

The role focuses on interpreting customer requirements, implementing action plans, and acquiring equipment and tools as needed. You will verify products at all stages with proper controls and instructions.

Competenze

• Bachelor's or Associate degree with 5+ years in quality engineering in medical device or related fields.
• Experience with 21 CFR Part 820 and 21 CFR Part 4 in quality systems.
• ISO 13485 knowledge and ability to read 2D drawings.
• Strong problem solving, documentation and continuous improvement mindset.

Mansioni

• Test raw materials and finished goods per SOPs.
• Maintain device history records and release checklists.
• Conduct in-process, in-coming, and final inspections.
• Prepare DMR and DHR documents.
• Coordinate calibration and metrology activities.
• Prepare control plans, FMEA and CAPA reports.
• Support IQ/OQ/PQ validation and product qualifications.

Conoscenze

Quality Engineering

Metrology

Root Cause Analysis

FMEA

CMM Programming

Formazione

Bachelor's or Associate degree

Strumenti

VMS

CMM

Vernier Caliper

Micrometer

Height Gauge

MS Office (Word, Excel)

Descrizione del lavoro

SMC Ltd. in Massachusetts is seeking a Quality Engineer II for sustaining projects. You will collaborate with engineering, tooling, and manufacturing to ensure robust quality systems, inspection methods, and tools across molding and assembly processes.

The role focuses on interpreting customer requirements, implementing action plans, and acquiring equipment and tools as needed. You will verify products at all stages with proper controls and instructions.