Quality Engineering Manager

Overview

The Quality Engineering Manager leads the quality engineering function across sustaining and new product development activities. This role ensures robust design quality practices are applied throughout the product lifecycle while also sustaining and improving manufacturing performance. The Quality Engineering Manager provides technical leadership, supervises a team of quality engineers, and serves as a key liaison between Quality, Engineering, and Operations.

The role is responsible for driving continuous improvement initiatives, ensuring regulatory compliance, and embedding a culture of quality excellence aligned with business objectives.

Responsibilities

• Manage, mentor, and develop a team of quality engineers across sustaining and design functions. Set clear goals, conduct performance reviews, and support career growth while ensuring effective resource planning and prioritization.
• Lead quality engineering support for new product development activities, including design controls, risk management (DFMEA/PFMEA), test method development, and validation. Ensure quality requirements are integrated throughout the product lifecycle and into production.
• Oversee resolution of product and process issues through nonconformance management, CAPAs, and customer complaint investigations. Drive effective use of root cause analysis tools and ensure timely closure with appropriate documentation.
• Monitor and improve quality metrics and KPIs; lead initiatives to reduce defects, improve process capability, and enhance product reliability using Lean, Six Sigma, and other structured methodologies.
• Ensure processes comply with ISO 13485, FDA QSR, and other relevant global regulations and standards. Support internal and external audits and inspection readiness activities, including those related to suppliers and contract manufacturers.
• Ensure validation and maintenance of critical measurement systems, sampling plans, and control methods. Proactively identify and mitigate risk throughout design and manufacturing processes.
• Serve as the quality engineering voice in cross-functional teams, partnering closely with R&D, Operations, Supply Chain, and Regulatory Affairs to drive quality excellence in product and process design.
• Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
• Travel requirements: 25% including international travel.

Job Qualifications/Requirements

• Bachelor’s degree (B.S.) in an Engineering, Technical, or Scientific field required
• Minimum of 8 years of relevant experience with at least 2 years in a leadership or mentorship capacity.
• Strong understanding of New Product Introduction (NPI) and Design Controls
• Demonstrated expertise in process validation, risk management, and root cause analysis
• In-depth knowledge of ISO 13485, FDA QSR, and applicable international regulations.
• Prior experience working in medical device industry preferred.