Quality Engineer II

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

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.

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


• Stable schedule


• Paid holiday and PTO


• Health, dental, and vision insurance


• 401(k) retirement savings


• Life and disability insurance


• Promotional opportunities


• Training and career growth programs


• Amazing co-workers


• Tuition reimbursement


• 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.

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