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
Quality Engineering Manager • Allen, TX, United States
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