Director, Design Quality

About the role

The Director, Design Quality Assurance leads the Design Quality Assurance function across the product lifecycle, ensuring compliance with regulatory requirements, industry standards, and internal procedures. This role provides strategic leadership for Design Quality, Design Controls, Risk Management, Reliability, and Product Lifecycle Quality activities.

Responsibilities

• Strategic Leadership
• Develop and execute the organization's Design Quality Assurance strategy aligned with business objectives and product development goals.
• Lead the Design Quality Assurance organization, including Design Quality Managers, Design Quality Engineers, and Reliability Engineers.
• Establish a Design Quality Center of Excellence that drives Quality and Reliability standardization, best practices, and continuous improvement across development and sustaining programs.
• Provide strategic Quality leadership to executive management regarding product Quality, Reliability, regulatory compliance, and risk management.
• Develop organizational capabilities, succession plans, and talent development strategies for the Design Quality function.
• Product Development & Design Controls
• Ensure effective implementation of Design Controls throughout the product lifecycle.
• Lead Quality participation in product development programs from concept through commercialization.
• Ensure Quality deliverables are completed on schedule and support stage-gate and design review processes.
• Partner with R&D and program management teams to proactively identify and mitigate product and project risks.
• Provide guidance on design inputs, design outputs, verification, validation, usability, software quality, and design transfer activities.
• Drive integration of Quality engineering principles into product development processes to yield acceptable product Quality.
• Reliability & Risk Management
• Oversee implementation and continuous improvement of risk management processes in accordance with applicable standards.
• Ensure product risk assessments are conducted and maintained throughout the product lifecycle.
• Provide leadership for Reliability methodologies and Reliability growth programs.
• Establish Reliability performance objectives and monitor achievement of Reliability targets.
• Direct Reliability Laboratory operations, ensuring effective management of test methods, test scheduling and execution, calibration systems, equipment qualification and maintenance, laboratory resources, and data integrity to support timely and high-quality product related decisions.
• Drive root cause analysis and risk-based corrective actions related to design and Reliability issues to improve product Quality.
• Sustaining Product Quality
• Provide leadership for Quality support of sustaining engineering activities.
• Ensure appropriate Quality oversight of design changes, product improvements, and lifecycle management initiatives.
• Lead teams during investigation and resolution of design-related field issues, complaints, and corrective actions.
• Utilize post-market surveillance data to drive product improvements and risk reduction.
• Cross-Functional Collaboration
• Serve as the primary Quality representative on product development leadership teams.
• Collaborate with Manufacturing, Supplier Quality, Operations, Marketing, Sourcing, and Regulatory Affairs to ensure successful product realization.
• Influence decision-making through data-driven analysis and risk-based recommendations.
• Foster a culture of accountability, innovation, and continuous improvement.
• Quality Systems & Regulatory Compliance
• Ensure compliance with applicable regulations and standards, including FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971, MDSAP, and applicable global regulations.
• Drive continuous improvement of Design Control, Risk Management, and Product Lifecycle Management processes.
• Support supplier audits, internal audits, external audits, and regulatory inspections.
• Collaborate with Regulatory Affairs to ensure effective regulatory submissions and compliance strategies.
• People Leadership
• Recruit, develop, coach, and retain a high-performing Design Quality team.
• Establish clear objectives, performance expectations, and development plans.
• Provide mentoring and technical guidance to Quality professionals.
• Build organizational capability to support future business growth and technology advancements.

Requirements

• Bachelor’s degree in Engineering or related technical discipline.
• Minimum 10 years of progressive experience in Quality, Design Assurance, Product Development, or Engineering within a regulated industry.
• Demonstrated expertise in Design Controls, Risk Management, Reliability Engineering, Quality Systems, Product Development Processes, CAPA and Root Cause Analysis, and extensive knowledge of FDA, ISO 13485, ISO 14971, MDSAP, and applicable global regulations.
• Proven ability to lead organizational change and continuous improvement initiatives.
• Exceptional leadership manifested through organizing and motivating teams toward their respective goals by employing hands-on management.
• Experience working within an R&D environment and NPD programs.
• Experience leading global or multi-site Quality organizations.
• Experience with statistical analysis software.
• Project Management Professional (PMP) Certification preferred.

Qualifications

• Bachelor’s degree in Engineering or related technical discipline.
• Master’s degree in Engineering, Quality, or Business Administration preferred.
• Medical device industry experience preferred.
• Experience working within an R&D environment and NPD programs preferred.
• Experience leading global or multi-site Quality organizations preferred.
• Experience with statistical analysis software preferred.
• Project Management Professional (PMP) Certification preferred.

Skills

• Excellent project management skills and ability to manage multiple high priority situations at once.
• Excellent problem-solving skills.
• Focus on identification of potential issues and continuous improvement.
• Experience working on cross-functional teams and on own initiative.
• Demonstrated leadership skills including conflict resolution, assertiveness, and negotiation skills.
• Experience in successfully coordinating with cross-functional departments (e.g., Legal, Regulatory, Operations, Supply Chain, Scientific Affairs, Marketing, Quality, Service, etc.).
• Demonstrated ability to make sound data-driven business decisions.
• Strong attention to detail.
• Demonstrated excellent organizational, oral, and written communications skills.
• PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.

Pay

The pay range for this opportunity is $144,500.00 - $187,000.00. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than range listed.

Benefits

STERIS offers a comprehensive and competitive benefits portfolio, including market competitive pay, extensive paid time off and (9) added holidays, excellent healthcare, dental, and vision benefits, long/short term disability coverage, a 401(K) with company match, tuition reimbursement and continued educational programs, and additional add-on benefits/discounts for programs such as pet insurance. For a complete list of benefits, click here: STERIS Benefits.