Quality Engineering

1 week ago

allen, United States Quest Medical, Inc. Full time

Summary:

Manages the Quality Engineering team to support new product development, process quality, CAPA, post-market compliance, supplier management, project management, internal & external auditing, and risk management activities with respect to global regulatory requirements and MDSAP (FDA, ISO, EU MDR, ANVISA, MHLW, and TGA).


General Duties and Responsibilities:

  • Ensure the ongoing integrity, adequacy, and appropriateness of the Quality Management System and associated processes.
  • Provide technical support, leadership and quality guidance to multi-functional teams, including Quality, Regulatory, R&D, Operations, Engineering, and Marketing.
  • Select, develop, and evaluate Quality Engineering staff to support all aspects of design and manufacturing quality.
  • Act as assistant to the Management Representative during regulatory and customer audits.
  • Develop and implement and improve efficient quality systems processes.
  • Utilize project management strategy at a department level to successfully execute multiple projects with competing resources and prioritization.
  • Establish and maintain quality metrics and utilizes KPIs to drive improvements.
  • Manage the CAPA program (to include Complaints, SCARs, NCMRs, Audit Non-Conformances and Corrective & Preventive Action projects). Ensure thorough investigations and implement effective corrective actions to prevent recurring issues.
  • Utilize root cause analysis and statistical techniques for complex problem solving of technical product and manufacturing issues.
  • Ensure a high level of supplier quality through effective supplier evaluation, approval, and monitoring processes. Collaborate with internal supply chain and external suppliers to drive continual improvement of supplier quality.
  • Develop and maintain FMEAs, Controls Plans, and SOPs to identify and mitigate risks.
  • Support the development and validation of new products and production lines.
  • Write, review, and approve documents (SOPs, Protocols, Reports, and ECOs) pertaining to key quality system elements affecting product quality.
  • Apply basic risk management principles to all aspects of the quality system.


Qualifications:

Required:

  • Technical Engineering or Science degree at the Bachelor level or above.
  • 8+ years of quality engineering experience in a highly regulated industry.
  • 3+ years managing team members with varied backgrounds, experience, and technical capabilities.
  • Excellent working knowledge of medical device regulations and industry standards pertaining to manufacturing (FDA 21 CFR Part 820, ISO 13485, EU MDR (2017/745), the Medical Device Single Audit Program (MDSAP), and ISO 14971), IEC 60601..
  • Demonstrated project management skills, including the ability to prioritize and manage multiple project workloads in a highly dynamic production environment.
  • Solid working background utilizing quality management methods and tools (CAPA, Root Cause Analysis, FMEA, Control Plans, Statistical Techniques, MSA, etc.)
  • Demonstrated experience using trending and analysis reporting to drive organizational improvements.
  • Ability to develop and deliver clear communications (written and verbal), ensuring timely and relevant communication.
  • Some travel, domestic or international, may be required (up to 25%).

Preferred

  • ASQ Certified Quality Manager or Certified Quality Engineer
  • ISO 13485 Lead Auditor
  • Lean Six Sigma Green Belt or Black Belt
  • Working knowledge of IEC 60601 and IEC 62366
  • Experience with sterile product assembly and packaging
  • Experience with electronics assembly

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