Manufacturing quality engineering

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.

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 conduct inspections at in-process, in-coming and complete the final inspections.

To prepare technical documents like DMR & DHR.

Creating master documents to track calibration & latest version of documents and records.

To prepare control plan, FMEA & FAIR documents.

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.

FAIR inspection, DHR & control of documents.

Equipment experience with: 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 understand the use all Quality related inspection equipment
• Must have computer skills and familiarity with Word and Excel programs
• Experience within medical device manufacturing within a contract manufacturing setting.

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

Paid holiday and PTO

• Health, dental, and vision insurance
• 401(k) retirement savings
• Life and disability insurance
• Training and career growth programs
• 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.