Quality Coordinator

About SMC Ltd: 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: Responsible to organize and moderate quality assurance and control activities to ensure products and services meet organizational and regulatory standards. Coordinate calibration activities, Material Review Board (MRB) records with dispositions, product inspections, manage customer required data documentation, and implement quality improvement initiatives. Provides support as a technical resource for departmental activities and requirements. Essential Job Duties and Responsibilities: Calibration: Manage gage control and calibration systems compliance with internal procedures and external requirements. Perform in-house calibrations and update corresponding Gage & Device records Create and manage Gage & Device records within ERP systems Coordinate external vendors to obtain quotes and schedule calibration services Generate purchase orders (PO) for calibration services Maintain gage traceability and calibration certifications records including conducting gage calibration incident reviews Material Review Board (MRB): Maintain the Material Review Board systems compliance Document and oversee disposition activities for MRB records within ERP system; ensuring completeness, accuracy, and timeliness of actions and closure Initiate MRB records for identified non-conformances, ie Expired Material, ECO relabel Quality Support: Training of in-process inspectors on measurement methodology and standard operating practices as directed. Prepare customer required quality data and documentation, ie SQM, MQP Coordinate sterilization documentation and communicate with outsource vendors, customers, and internal shipping departments for outgoing product shipments. Serve as a backup to other Quality roles Ensure data is being collected and retained per company policies and procedures. Maintains a working knowledge of industry quality assurance codes and standards. Organize problem solving in the areas of scrap, process capability, etc. Conduct system and product audits. Other duties as assigned. Essential Qualifications: High School Diploma or equivalent required. Knowledge of Quality Management Systems (ISO 13485, 9001) Knowledge of ISO 17025 Testing & Calibration Standards Problem solving training a plus; Six-Sigma Black/Green Belt/Lean-Kaizen Attention to detail and ability to manage multiple tasks Strong mathematics skills, basic knowledge in statistics, and mechanically inclined. At least 2 years of experience in a quality function Strong training, communication and management skills. Desirable Qualifications: Experience in a Medical Device or Pharmaceutical regulated industry a plus. ASQ certification a plus; CQE, CQM, CQA 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 to30lbs. occasionally, >20. 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. #IND #LI-HN1

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