Quality Engineering Manager

POSITION SUMMARY

The Quality Engineering Manager leads and participates in continuous improvement activities across all business areas, focusing on instrumentation, chemistry, software, and testing. The role is responsible for directing and prioritizing tasks to ensure timely and accurate completion of tests and records, supporting efficient product delivery.

This role reports into the Site Quality Lead.

• Manage the daily activities of work groups and technicians, ensuring alignment with project goals.
• Lead problem‑solving efforts for all aspects of testing, driving timely and effective solutions.
• Generate, implement and review Standard Operating Procedures (SOPs) and Standard Methods.
• Ensure all testing is properly documented and conducted in accordance with written protocols.
• Oversee the training and competency of PSG technicians.

• Analyze data to identify areas of product opportunities for improvement.
• Design and execute experiments to expose and address product risks.
• Support development of specialized test fixtures, software, and systems for required testing.
• Analyze and report on product field performance, including issuing summary reports.
• Assist in failure analysis of returned materials, components, and subassemblies.
• Initiate actions to enhance product robustness and reliability.
• Support the development and implementation of process improvements in manufacturing.
• Establish and refine process limits, and develop appropriate inspection and test methods for production processes.

• Implement and maintain a quality risk management process to monitor, control, and improve process performance and product quality throughout the product lifecycle.
• Ensure the use of operational excellence tools in quality procedures and processes.
• Provide QA support to validation activities, including participation in project teams for facilities, equipment, utilities, cleaning, and process validation.
• Prepare and maintain the site Validation Master Plan in compliance with current requirements.
• Oversee qualification protocol and reports, providing quality oversight and assessment.
• Review and approve process‑related change controls and change plans.
• Identify and communicate potential compliance gaps or risks to management.
• Participate in inspection readiness and preparation activities, including support during regulatory site inspections.

• Drive continuous improvement initiatives to enhance cycle time, productivity, efficiency, and quality of work, utilizing Lean methodology.
• Understand and support business needs, provide quality guidance, and facilitate timely resolution of quality issues.

• Foster leadership development and coaching among staff, creating a learning organization.
• Ensure training and development plans are established and implemented for all QA associates.
• Develop budgets and resource plans for integration into the Site Quality Budget.
• Support the development of quality goals and targets as part of the organization's strategic plans.

• Colleague will interact with colleagues throughout the entire facility, including working with Quality, Engineering, Operations, etc.

• PSG Team
• Quality Engineers
• Software Engineer

• B.S. in a science or technical area or 5-10 years' experience in a science related field.

• Understanding of ISO 13485 & FDA 21
  
  CFR
  820. Ability to ensure compliance with changing guidelines.
• Ability to troubleshoot problems and implement corrective action.
• Good written and oral communication skills.
• Understanding of equipment used by technicians.
• Analytical problem‑solving skills.
• Experience with software programs including Excel, PowerPoint, Word, Minitab or JMP.
• Strict attention to detail is critical and required as well as effective written and oral communication skills.
• Use of statistical techniques, reliability test methods, electro‑mechanical aptitude and software programming.
• Able to quickly analyze and solve problems by applying an analytical,…