Quality Engineer II

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.

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.

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.

• 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.

• 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

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

• 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

• 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…