Quality Management Specialist

6 days ago

Vaughan, Ontario, Canada J. Sterling Industries Full time
Quality Engineering Specialist

At J. Sterling Industries, we're seeking a highly skilled Quality Engineering Specialist to join our growing team. As a key member of our quality department, you'll play a vital role in ensuring the highest standards of quality and regulatory compliance in our medical device manufacturing processes.

Key Responsibilities:

  • Develop and implement quality-related processes and documentation for new program development and current sustainment business.
  • Collaborate with cross-functional teams to drive continuous improvement and meet or exceed quality metrics.
  • Analyze and resolve customer/internal/supplier quality issues through root cause analysis and implementation of corrective actions.
  • Manage the non-conformance area, including inventory, disposition, and associated costs.
  • Purchase, manage, and review gage equipment, certifications, and calibrations.
  • Ensure the Gage calibration log is complete and up to date.
  • Coordinate with the quality inspector for daily inspections, measurements, tests, and approvals.
  • Communicate and coordinate with management, administrative, operations, quality, and engineering departments.
  • Daily use of quality management system software and SPC systems.
  • Participate in conducting supplier and internal system and process audits.
  • Additional duties as requested by management.

Requirements:

  • Engineering bachelor's degree, with background in quality statistics, metrology, biomedical technologies preferred.
  • 3-5 years' experience in a quality department in a medical device OEM or contract manufacturer ISO registered environment.
  • ISO 13485:2016 Auditor Training Certificate preferred.
  • High volume workload requires a conscientious attitude with accuracy and attention to detail.
  • Knowledge and experience on ISO 9001:2015, process capability, problem-solving methods, and medical device product development phases.
  • Six Sigma certifications a plus (green belt or higher).
  • Proficient in Microsoft office (outlook, excel, word, power point).
  • Excellent communication skills (oral, written, technical).
  • Excellent time management skills and the ability to be self-directed.
  • Customer focus and continuous improvement approach.
  • Experience with machining, fabrication, and assembly operations a plus.
  • Must be able to work a flexible schedule and lift minimum 40 pounds.
  • The position will require some travel (USA and Canada).

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