Location: California,MD, USA
Work Flexibility: Hybrid
About Stryker's Endoscopy Business Unit
Stryker's Endoscopy Business Unit is dedicated to advancing minimally invasive surgical techniques through innovative visualization, instrumentation, and data solutions. Our portfolio empowers surgeons with cutting-edge technology designed to enhance procedural precision, improve patient outcomes, and increase efficiency in the operating room. By combining advanced imaging systems, specialized instrumentation, and integrated data management, we strive to provide healthcare professionals with tools that support better decision-making and patient care. At Stryker Endoscopy, we are constantly pushing the boundaries of innovation to shape the future of surgical solutions and improve lives worldwide.
Job's Mission
The Director of Quality Assurance will play a crucial role in ensuring the highest standards of product quality across the full lifecycle, from new product development through post-market support, for one of Stryker's fastest-growing business units. This position will lead quality initiatives, driving continuous improvements and managing compliance with regulatory standards to support the company's mission of delivering life-enhancing products.
As the Director of Quality Assurance, you will oversee and enhance product quality in both design and post-market phases. Leading a team of engineers and managers, you will drive the launch of high-quality products and implement ongoing quality improvements. Collaborating closely with customers, the salesforce, and cross-functional teams, you will ensure that products consistently meet quality and regulatory requirements. Additionally, you will manage financial cost centers and oversee all hiring, development, and performance management activities within the quality assurance team, fostering a culture of excellence and compliance.
Essential Duties & Responsibilities
* Product Quality Leadership
* Oversee new product development (design) quality and post-market (customer) product quality, driving quality improvements across the product lifecycle.
* Provide strategic direction within the Quality Engineering organization and establish quality metrics and KPIs to ensure product performance.
* Team Leadership and Development
* Lead and develop a team of engineers, managing performance and addressing issues to meet or exceed quality goals.
* Recruit, onboard, and nurture talent, focusing on year-over-year improvements in team impact and capability.
* Maintain a high level of team engagement, fostering a collaborative and productive work environment.
* Cross-Functional Collaboration
* Build and leverage relationships with cross-functional leaders, coordinating efforts to meet quality objectives.
* Conduct quality reviews with senior leadership, providing insights on product quality and field performance.
* Actively participate in design and development teams, ensuring new products meet user requirements and industry standards.
* Regulatory Compliance and Quality Assurance
* Ensure product compliance with FDA and international regulatory standards, maintaining high-quality products in the market.
* Design and implement comprehensive quality engineering programs and oversee engineering changes through internal change controls.
* Represent the organization in FDA and regulatory audits and support complaint handling, MDR-MDV reporting, and product field actions.
* Financial and Operational Management
* Manage cost centers for the quality assurance team, balancing budget and performance.
* Travel up to 30% to engage with customers, sales teams, and other global sites as needed.
Job Requirements
Location: This is a Hybrid Role requiring at least 3 days a week at our Flower Mound, Texas or San Jose, CA Locations
Education & Special Training
* Bachelor's degree required, preferably in Computer Science, Engineering, Information Technology, or a related field.
* Six Sigma certification and experience preferred.
* CQE (Certified Quality Engineer), CQM (Certified Quality Manager), or PE (Professional Engineer) certification is a plus.
Qualifications & Experience
* 2-4 years of experience overseeing Software Quality initiatives, with a focus on ensuring product reliability and compliance in digital products or software solutions.
* Minimum of 12 years of experience in design and product development, preferably in the Medical Device industry.
* At least 4 years of management experience, with a demonstrated ability to lead and achieve results through others.
* Proven experience in managing subordinates in professional roles or leading cross-functional teams, including those who are not direct reports.
* Ability to establish strategic plans and operational programs with a deep understanding of relevant theories and business practices.
* Full management responsibility, including oversight of multiple teams of managers and professionals, as well as budget and financial accountability for independent budgets.
Skills & Abilities
* Strong communication skills, with the ability to inspire large groups and effectively present to senior leadership.
* Competence in reviewing technical documentation, creating detailed proposals, and communicating complex quality guidelines and procedures to both departmental and non-departmental personnel.
* Excellent analytical skills, with the ability to perform root-cause analysis and solve non-routine product issues independently.
* Ability to make impactful decisions that affect immediate operations and potentially have a company-wide effect.
* Detail-oriented, capable of identifying and correcting inconsistencies across teams and business processes.
* Strong interpersonal skills, effective team management, and organizational skills.
* Comfortable communicating with customers and field teams to address product quality and regulatory concerns.
* Highly accountable, with a results-driven approach to team and project management.
* $160,000 - $270,000 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 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.