Director, Quality Assurance - Sports Med

Work Flexibility: Hybrid

Job's Mission

The Director of Quality Assurance will play a crucial role in shaping and executing quality assurance strategies for one of Stryker’s fastest-growing business units. This leadership role is responsible for the entire product quality lifecycle—overseeing quality from New Product Development (NPD) through to end-of-life. As a key member of the leadership team, you will drive quality initiatives to ensure products meet the highest standards for performance, safety, and compliance.

Key Responsibilities

Strategic Quality Leadership

• Develop and implement quality assurance strategies that support business growth and operational excellence.
• Influence the direction of divisional QA activities, particularly in Design and Customer Quality.

Quality Ownership Across Product Lifecycle

• Oversee quality from cradle-to-grave, covering all aspects from NPD through post-market and product obsolescence.
• Launch new products with high quality standards and ensure efficient resolution of post-launch quality issues.
• Collaborate with cross-functional teams, including Sales, Marketing, R&D, Product Engineering, Field Service, Operations, and Project Management, to uphold product quality standards.

Regulatory Compliance and Process Management

• Ensure that manufacturing and product development processes adhere to international standards and regulatory requirements.
• Establish standardized processes for the timely resolution and management of quality tasks.
• Manage and lead meetings to resolve quality issues and track closure.

Metrics and Auditing

• Monitor, update, and enhance quality metrics to improve overall performance.
• Conduct thorough reviews of regulatory compliance requirements, particularly for device manufacturing in global markets.
• Support quality system changes to stay compliant with evolving regulations and standards.
• Represent quality processes during internal and external audits.

People Leadership

• Define and manage individual performance targets, KPIs, and objectives for team members.
• Recruit, onboard, and develop top talent within the quality assurance team.
• Actively address performance issues and foster a high level of engagement within the team.

What You Will Bring

• Proven experience in a senior quality assurance role within a regulated environment, preferably in the medical device, healthcare, or life sciences industries.
• Strong knowledge of international quality standards and regulatory requirements.
• Demonstrated success in leading cross-functional quality initiatives and improving quality metrics.
• Experience with full lifecycle quality management, from NPD to post-market.
• Exceptional leadership skills, with a track record of building and managing high-performing teams.

Job Requirements

Education and Experience

• Bachelor’s Degree in Engineering or a related field (Master’s Degree preferred).
• Minimum of 10 years’ experience in a manufacturing and product development environment (Medical Device industry experience highly desired).
• 2-4 years of experience as a management experience, with a focus on Design and Customer Quality, Design Assurance, or R&D.

Certifications and Technical Skills

• Six Sigma certification and formal training in Quality Systems are highly desired.
• Certifications such as CQE (Certified Quality Engineer), CQM (Certified Quality Manager), or PE (Professional Engineer) are preferred.

Key Skills and Abilities

• Excellent analytical skills, with the ability to evaluate and solve non-routine product issues independently.
• Strong interpersonal and communication skills, able to communicate with large groups and present detailed proposals and guidelines effectively.
• Demonstrated organizational and managerial skills, with a history of effective team leadership.
• Ability to make impactful decisions affecting immediate operations and potentially company-wide.

Additional Requirements

• Hybrid Role: This role will require an onsite presence at our Colorado Location, with a minimum of 3 days onsite
• Comfortable with frequent review and correction of minute inconsistencies (in documents, production processes, product quality, etc.).
• Willingness to travel (approximately 25%) and work in various environments, including operating rooms, cadaver and animal labs, and customer locations globally.
• Strong attention