Quality Engineer II- Sustaining Projects

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

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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