Director, Design Quality

STERIS Corporation•Mentor, OH

31d•$144,500 - $187,000

About The Position

The Director, Design Quality Assurance is responsible for leading the Design Quality Assurance function across the product lifecycle, ensuring that new and sustaining products are developed, transferred, and maintained in compliance with applicable regulatory requirements, industry standards, and internal quality system procedures. This role provides strategic leadership for Design Quality, Design Controls, Risk Management, Reliability, and Product Lifecycle Quality activities. The Director, Design Quality Assurance partners closely with Research & Development, Marketing, Regulatory Affairs, Manufacturing, Sourcing, and Post-Market Surveillance teams to ensure Quality and Reliability are proactively embedded throughout product development and commercialization activities. The position serves as the primary Quality leader for New Product Development (NPD) programs, Reliability functions, and Sustaining Engineering activities. The Director establishes a culture where Quality is a competitive advantage, enabling innovation while ensuring patient safety, product effectiveness, and regulatory compliance.

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.
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.
The ability to work hard and deliver results under pressure, as well as the willingness to address and shift priorities in rapidly changing markets.
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.
Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.

Nice To Haves

Master’s degree in Engineering, Quality, or Business Administration.
Medical device industry experience.
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.

Responsibilities

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 Assurance 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.
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.
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.
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.
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
Ensure compliance with applicable regulations and standards, including: FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971, EU MDR, MDSAP, Other applicable regional regulations and standards
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.
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