Senior Manager, Quality Engineering & Quality Assurance

About the Role

This position manages the Metal Manufacturing team to ensure smooth and continuous operations of the site quality system, quality control, and assurance inspection for in-process and finished goods. The Senior Manager, Quality Engineering & Quality Assurance oversees process audits, final product release documentation, and facilitates failure investigations and compliance methodologies for manufacturing metal components. The role focuses on implementing and optimizing quality engineering practices while fostering a culture of quality and compliance with global regulatory requirements.

Responsibilities

• Serve as the quality representative for metals during internal and external audits.
• Coordinate with Draper Quality Systems Management for audit preparation, execution, and action plans.
• Ensure the Metals Organization executes Draper site quality objectives and plans.
• Manage supervisors and oversee the work of the quality assurance team within the function, production line, or projects.
• Develop a robust talent development plan aligned with functional growth strategies.
• Identify opportunities and lead the implementation of changes to drive improvements.
• Manage quality assurance project activities (e.g., CAPA) with accountability for successful completion within established schedule, scope, and quality objectives, including training, approvals, and system effectiveness.
• Identify risks, develop mitigation strategies, and resolve issues in collaboration with cross-functional groups.
• Collaborate with cross-functional groups to manage inspection of in-process and finished goods, assemblies, and components.
• Negotiate solutions with cross-functional groups (e.g., Manufacturing Operations, Supply Chain, and Engineering) for continuous improvement.
• Manage project activities using engineering methods (e.g., Six Sigma and LEAN) to redesign or design new products and processes.
• Provide technical guidance to cross-functional and departmental groups to develop design recommendations for components or products with moderate complexity.
• Collaborate with Campus Model shared services to support the Draper Metals Organization.

Requirements

• Bachelor’s degree in Materials, Chemical, Mechanical, Metals Engineering, or a related field.
• Experience in Quality Engineering or Quality Management within the medical device industry with demonstrated product quality decision-making.
• Demonstrated track record in management of technical and/or engineering disciplines in a dynamic Quality/Manufacturing environment.

Preferred Qualifications

• Technical quality leadership experience supporting metals manufacturing, metal components, or precision-manufactured components.
• Experience supporting commercial production quality for processes such as machining, forming, chemical processing, laser cutting, tubing, nitinol, or other metal component manufacturing.
• Demonstrated experience leading both Quality Engineering and Quality Assurance functions, including oversight of NCRs, CAPAs, TMVs, inspection readiness, product release, and quality metrics.
• Experience managing supervisors and associated direct and indirect manufacturing inspection and/or testing resources.
• Experience managing or partnering closely with inspection, quality control, and manufacturing operations teams to ensure in-process and finished goods meet quality, compliance, and release requirements.
• Medical device external audit leadership experience.
• Proven ability to serve as a quality representative during internal, notified body, FDA, customer, or external regulatory audits, including audit preparation, execution, response, and action plan management.
• Strong working knowledge of applicable medical device quality system and regulatory requirements, including FDA Quality System Regulation, ISO 13485, GMP, and global quality standards.
• Experience using quality engineering tools and statistical methods such as process capability, statistical process control, FMEA, DOE, test method validation, root cause analysis, Lean, and Six Sigma.
• Demonstrated ability to lead technical quality investigations, drive risk-based decision-making, and implement sustainable corrective and preventive actions in a high-volume or complex manufacturing environment.
• Experience developing and using quality metrics, management review inputs, and operational dashboards to monitor trends, communicate risks, and drive continuous improvement.
• Certified Quality Engineer, Six Sigma Black Belt, Lean certification, or equivalent quality/manufacturing certification.