Quality Engineer II – Sustaining Projects | Growth

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

Benefits offered by this job

Clean, Climate-Controlled Environment

Paid holiday and PTO

Health, dental, and vision insurance

401(k) retirement savings

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, ensuring robust inspection methods and controls are in place.

You will work with engineering, tooling and manufacturing to meet customer requirements through action plans, equipment investments, and compliant processes. The role emphasizes DOEs in metrology, calibration oversight, and documentation such as DMR, DHR, and control plans, with a strong focus on ISO 13485 and CFR compliance within a

Qualifications

• Bachelor's or Associate's degree with 5 years of experience in quality engineering
• 5-7 years’ experience in quality engineering within drug and medical device industries
• Experience with 21 CFR Part 820 Quality System Regulation
• Experience with 21 CFR Part 4 Combination Product Regulation
• Experience with ISO 13485
• Ability to read and understand 2D detailed part drawings
• Familiarity with quality inspection equipment and metrology tools
• Strong problem solving and mistake-proofing skills
• Computer skills including Word and Excel
• Knowledge of SPC
• Leadership and teamwork in a matrixed organization
• Excellent written, verbal, and presentation skills

Responsibilities

• Ensure RAW Material / Packing Material and finished goods testing per SOPs
• Maintain device history records (DHR) and product release checklists
• Conduct inspections at in-process, in-coming, and final stages
• Prepare technical documents like DMR and DHR
• Maintain microbial records per ISO class-7 & class-8 procedures
• Create master documents to track calibration and document versions
• Prepare control plans, FMEA and FAIR documents
• Prepare 8D and supplier CAPA reports
• Monitor calibration activities
• Perform metrology activities and drawing reviews
• Coordinate investigations, root cause analysis and corrective actions
• Work with metrology equipment such as VMS and CMM programming
• Ensure product and process validation requirements and implementation
• IQ, OQ, PQ validation/qualification
• Adhere to ISO 13485 and ISO 9001 standards
• Maintain FAIR inspections, DHR and document control
• Demonstrate strong technical, analytical and troubleshooting skills
• Operate equipment including VMS, CMM, Vernier calipers, micrometers, height gauges

Skills

Problem solving

Leadership

Communication

Reading 2D drawings

Interpersonal skills

SPC knowledge

MS Office

Quality systems knowledge

Education

Bachelor of Science or Associate's degree

Tools

VMS

CMM programming

Job description

SMC Ltd. is seeking a Quality Engineer II to oversee quality engineering across molding and assembly, ensuring robust inspection methods and controls are in place.

You will work with engineering, tooling and manufacturing to meet customer requirements through action plans, equipment investments, and compliant processes. The role emphasizes DOEs in metrology, calibration oversight, and documentation such as DMR, DHR, and control plans, with a strong focus on ISO 13485 and CFR compliance within a