Quality Analyst - 1st shift M-F

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.

• Works Independent with minimal technical guidance, relies on experience and judgement to plan and accomplish goals.
• Ability to coach, mentor and train others on all jobs within the department
• Works with Engineering, Production and Quality to complete the Batch process
• Redlining /relabeling activities through an ECO process
• May assist with NPD (New Product Development) launch
• attend Pre-PQ (Performance Qualification) meetings as required
• Supporting ISO 13485 system requirements
• Maintain gaging calibration cycles working with all departments. This includes generating GNR/ANR/PO/IRF and certifications.
• Maintain Tailgate samples and delivery to warehouse for shipment
• Assisting Quality Inspectors to ensure they have all tools necessary to perform their daily tasks
• May perform internal audits per ISO Internal Audit Schedule
• May cover Quality Inspector role as needed
• May be required to monitor pressure/temperature monitors
• Maintain a clean, neat, and organized working area with the help of the QA inspectors
• Supporting an investigation for any Quality failures and improvements
• Regular attendance, punctuality and professionalism
• Other duties as assigned

• Action Oriented –Ability to take on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm.
• Collaborates –Builds partnerships and works collaboratively with others to meet shared objectives.
• Decision Quality –Makes good and timely decisions that keep the organization moving forward.
• Drives Results –Consistently achieves results, even under tough circumstances.
• Ensures Accountability –Holds self and others accountable to meet commitments.
• Instills Trust
  – Gains the confidence and trust of others through honesty, integrity and authenticity.

• High school diploma or equivalent experience.
• Minimum 6 years of Quality experience in the plastics industry, clean room/medical device assembly.
• Knowledge and practical understanding of various assembly Inspection methods and inspection equipment.
• Attention to detail and ability to manage multiple tasks and priorities.
• Excellent interpersonal and communication skills
• Proficient PC skills in a windows environment, Microsoft Word and Excel.
• Working knowledge of ISO, FDA, GMP, and OSHA standards preferred.
• Ability to read, write and communicate in English.

• 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

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 accommodations during the interview process.

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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