Manager, Quality Engineering

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). 
• 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