Director, Quality Assurance - Sports Med

$160,000 - $245,000/Yr

Stryker - Greenwood Village, CO

Full-time - Senior

Greenwood Village, CO

1,001-5,000 employees

Merchant Wholesalers, Durable Goods

About the position

The Director of Quality Assurance will lead quality assurance strategies for Stryker's rapidly growing business unit, overseeing the entire product quality lifecycle from New Product Development (NPD) to end-of-life. This leadership role is crucial in ensuring that products meet the highest standards for performance, safety, and compliance, while driving quality initiatives across various teams.

Responsibilities

• Develop and implement quality assurance strategies that support business growth and operational excellence.
• 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 to uphold product quality standards.
• 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.
• Monitor, update, and enhance quality metrics to improve overall performance.
• Conduct thorough reviews of regulatory compliance requirements for device manufacturing in global markets.
• Define and manage individual performance targets, KPIs, and objectives for team members.
• Recruit, onboard, and develop top talent within the quality assurance team.

Requirements

• 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.
• 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 management experience, focusing on Design and Customer Quality, Design Assurance, or R&D.
• Six Sigma certification and formal training in Quality Systems are highly desired.

Nice-to-haves

• Certifications such as CQE (Certified Quality Engineer), CQM (Certified Quality Manager), or PE (Professional Engineer) are preferred.

Benefits

• 401(k)
• AD&D insurance
• Dental insurance
• Disability insurance
• Employee stock purchase plan
• Flexible spending account
• Health insurance
• 12 paid holidays annually
• Health Savings Account (HSA)
• Flexible Spending Accounts (FSAs)
• Short-term disability insurance
• Wellbeing program and tobacco cessation program