Quality Engineer II

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

Benefits offered by this job

Health insurance

Paid time off

401(k)

Life insurance

Disability insurance

Career growth

Training programs

EAP

Job summary

SMC Ltd. is seeking a Quality Engineer II to oversee quality engineering across molding and assembly operations.

You will work with engineering, tooling, and manufacturing to ensure proper systems, inspection methods, and tools are used to verify product quality throughout the process. The role requires strong analytical and leadership skills, experience with ISO 13485 and 21 CFR 820, and hands-on proficiency with metrology tools.

Qualifications

• Bachelor's or Associate's degree with 5+ years in quality engineering in medical devices/drug spaces.
• 5+ years of experience in Quality Engineering within medical device/drug industries.
• Experience with 21 CFR Part 820, 21 CFR Part 4, and ISO 13485.
• Ability to read and interpret 2D drawings and use quality inspection equipment.
• Strong problem solving and mistake-proofing skills.

Responsibilities

• Ensure raw/materials 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, DHR, and other quality documents.
• Lead calibration records and control documents.
• Create control plans, FMEA, and FAIR docs.
• Prepare 8D and supplier CAPA reports.
• Coordinate investigations and root-cause analyses.

Education

Bachelor of Science Degree or Associate's degree

Problem solving

Reading 2D drawings

Quality tools & inspection

Interpersonal skills

Tools

VMS

CMM programming

Vernier caliper

Micrometer

Height gauge

Job description

Salary Range: $64,600.00 To $110,000.00 Annually

About Us:

SMC Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people.

Job Summary:

The Quality Engineer II is responsible for all areas of Quality Engineering and working directly with the engineering, tooling and manufacturing functions making sure adequate systems, inspection methods and tools are used throughout the plants for molding and assembling products. Understanding customer requirements and implementing action plans, purchasing equipment or tools necessary to perform tasks. Ensure proper controls, operator instructions and quality tools used to verify customer’s products at all phases within our process.

Essential Job Duties and Responsibilities:

• To ensure Raw Material / Packing Material and finished goods testing in line with the SOPs.
• To maintain device history records (DHR) & product release checklist for each lot.
• To conduct inspections at in-process, in-coming and complete the final inspections.
• To prepare technical documents like DMR & DHR.
• To maintain microbial record in ISO class-7 & class-8 as per procedure.
• Creating master documents to track calibration & latest version of documents and records.
• To prepare control plan, FMEA & FAIR documents.
• To prepare 8D and supplier CAPA reports.
• Monitoring calibration activities.
• Perform metrology activities & drawing reviews.
• Coordinates investigation, root cause analysis & corrective action.
• Preferred skills in various metrology equipment, such as VMS, CMM programming, etc.
• Product & process validation requirements & implementation.
• IQ, OQ, PQ validation/qualification
• Working knowledge of the ISO 13485 & ISO 9001standards.
• FAIR inspection, DHR & control of documents.
• Good technical, analytical and trouble shooting skills.
• Equipment experience with: VMS, CMM, Vernier caliper, micrometer, height gauge, etc.

Essential Qualifications:

• Bachelor of Science Degree or Associate's degree with 5 years of experience
• 5-7 years’ of experience as a Quality Engineering within drug and medical device industries
• Must have experience with 21 CFR Part 820 Quality System Regulation
• Must have experience with 21 CFR Part 4 Combination Product Regulation
• Must have experience with ISO 13485
• Must be able to read and understand 2D detailed part/article drawings
• Must understand the use all Quality related inspection equipment
• Must have excellent problem solving and mistake proofing skills
• Must have computer skills and familiarity with Word and Excel programs
• Must have knowledge of SPC
• Effective interpersonal and problem solving skills
• Established track record in demonstrating strong leadership and managerial skills within a team-based, collaborative matrixed organization
• Excellent written, verbal, and presentation skills

Desirable Qualifications:

• Experience within medical device manufacturing within a contract manufacturing setting.

ADA Requirements:

• Stand, walk, bend, squat, twist, reach or otherwise move frequently
• Occasional repetitive motion and grasping
• Occasional climbing to reach areas on machines or racks
• Lift, move or otherwise transfer up to 50 lbs. occasionally, >20 lbs. frequently
• Typically sits, grasps items or performs keyboarding for occasional operation of a computer
• Exposure to typical machine shop physical hazards which may require respiratory protection
• Travel by air or car frequently

What SMC has to offer?

• 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

We are committed to fair and equitable hiring with salaries based on relevant factors, such as work experience, education, and certifications. Toward the principle of equal pay for equal work, we post and hire within defined salary ranges. We ask all applicants to review salary ranges for each posted job opportunity, as we will not hire outside the predetermined range.

At SMC Ltd. we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodation during the interview process.

All applicants must be authorized to work in the US

SMC Ltd. is an equal opportunity employer. M/F/D/V; this organization uses E-Verify.

Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.