Job Information
Stryker Sr. Director, Quality Assurance - Endoscopy in San Jose, California
We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf)
Basic Function
Set the vision, strategy, and direction for the Business Unit Quality Organization
Provide Business Unit leadership as part of the Business Unit General Manager’s leadership team. Along with cross-functional leadership team, support the direction, strategy, and growth of the business unit.
Accountable for ensuring the launch and distribution of quality products, compliance with all applicable quality and regulatory compliance requirements, maintaining product supply and providing positive customer experiences.
Responsibilities
Will serve as a leader within the business unit as part of the business unit leadership team. Participates in setting overall business unit strategy and goals. Able to effectively communicate, influence, and navigate issues at the executive level.
Participates on the Endoscopy Division Quality leadership team, helping set the strategy and direction for the overall Endoscopy Division Quality organization.
Creates the vision and strategy for the organizations of responsibility to drive alignment with business priorities, efficiency, collaboration, and improved process and services.
Hires, trains, supervises, mentors, motivates, and develops the leadership teams within each organization of responsibility. Conducts performance management.
Responsible for key metrics such as the Cost of Poor Quality, Customer Return Rate, Warranty Return Rate and Complaints per Million. In collaboration with business and finance leaders, sets goals for these key metrics to drive appropriate customer satisfaction and acceptable financial performance within the business P&L.
Accountable for the launch of high-quality products that meet user needs in new product design and development.
Accountable to the review, monitoring and trending of customer complaints to identify actions to improve product quality. Communicates directly with key customers when dealing with frustration or issues with our products. Develops a quality organization that interacts regularly with customers and sales representatives.
Sets the direction for the technical support organization, which provides prompt customer service for customer and sales rep calls for technical product assistance. Maintains satisfactory metrics such as call wait time, call drop percentage, etc.
Communicates regularly with cross functional business leaders including R&D, Marketing, Regulatory, Operations, Legal and Compliance. Drives culture with onsite presence.
Responsible for M&A due diligence activities from a quality perspective and influence into acquisition decisions; responsible for acquisition integration activities from a quality perspective.
Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets.
Responsible for supporting complaint handling, MDR-MDV reporting, and product field action decisions.
Participates in external audits including direct interaction with FDA, ISO (Notified Bodies), and other external auditors.
Support Quality System activities including NC/CAPA, Internal Audit, and change control.
May serve as Quality System Management Representative or alternative Management Representative.
Skills/Experience Required
Minimum of 15 years experience
Minimum of 10 years of People Management Experience
Minimum of 10 Years of experience overseeing quality in an R&D, NPD, NPI, or Design Quality Assurance Environment
Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements.
Demonstrated ability to work in a team environment, interact effectively with management from other functions.
Demonstrated ability to manage a multi-discipline, multi-technology, team-based organization and assume responsibility of quality, regulatory, and compliance targets.
Education/training required
Bachelor’s degree required, engineering preferred (mechanical, electrical, industrial, software, biomedical, etc.)
Location: This is a hybrid role, located in San Jose, CA
217,500.00 - 305,000.00 USD Annual S alary 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.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
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.