Stryker
Director, Quality Assurance - Sports Med
Stryker, Englewood, Colorado, us, 80151
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 to detail and ability to generate and explain quality-related guidelines, processes, and procedures to cross-functional teams.
$160,000- $245,000salary 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.
Travel Percentage: 20%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
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- $245,000salary 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.
Travel Percentage: 20%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.