Director, Quality Assurance - Sports Med

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 to detail and ability to generate and explain quality-related guidelines, processes, and procedures to cross-functional teams.

• $160,000 - $245,000 salary plus bonus eligible + generally eligible for short-term and long-term financial incentives + benefits.  Actual minimum and maximum may vary based on location.  Individual pay is based on skills, experience, and other relevant factors.
• This salary range is based on the current available market data and represents the expected salary range for this role. A broad range of experience is represented within our roles. Should you have compensation expectations that exceed these bands, we'd love to hear from you and would welcome you to reach out to discuss further.