Stryker Director Design Quality Engineering in Flower Mound, Texas
Why engineering at Stryker?
At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.
Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team
We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com
Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.
The Director Design Quality Engineering provides leadership to the division’s quality team to enable achievement of business goals through launching new, high quality innovative products to ensuring continuous distribution of safe and reliable products. This leader is accountable for ensuring cross-functional alignment and support to meet quality and regulatory compliance requirements, as well as, to drive product and/or customer experience improvements through the quality system. The Director Design Quality Engineering is responsible for a team of 6 direct reports, plus their respective teams, situated globally. This leader has a dual reporting relationship into the head of Quality for the division and the VP and General Manager of the Communications business, and is required to be located in Flower Mound, TX .
Provides a strategic direction and tactical focus to the Quality Engineering organization and influence the direction of the business unit.
Maintains and manages cost center for business unit Quality department.
Responsible for improvement of metrics/KPIs for business unit quality
Leverages relationships with cross functional leaders within business unit to set key goals.
Supports new product design and development teams to launch new products with high quality that meet user needs.
Directs and coordinates activities and operations of advanced quality engineering. Providing the leadership, mission, and vision for Quality organization.
Leads efforts to drive product quality improvements and fixes on launched products.
Works directly with customers, sales and field-based teams as needed.
Support M&A and business development activities as needed.
Participates and provides support during FDA and other global regulatory audits.
Involved in key projects across multiple business units.
Conducts periodic review of the Quality Program with senior leadership within the division.
Developing, implementing, and maintaining procedures focused on methods and processes involved in the manufacturing of products. Additionally, responsible for ensuring the quality and compliance of all products to Regulatory Standards within FDA and international guidelines.
Designs, develops, and implements comprehensive quality engineering programs.
Maintains, enforces, and measures quality assurance processes.
Responsible for ensuring, tracking, and reporting quality and reliability for released products.
Responsible for reviewing engineering changes to products via internal change control system for product changes.
Responsible for supporting complaint handling, MDR-MDV reporting, and product field action decisions.
Ensures that manufacturing, product development, and related functions are conducted in compliance with international standards and government regulations in support of company mission.
Chairs meetings required to drive closure of quality issues.
Defines targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets.
Recruits, selects, and on-boards top talent. Develop talent within team to increase performance. Actively address performance issues on team. Maintain a high level of team engagement.
BS in Engineering or other relevant field of study; Master’s degree or equivalent preferred.
Minimum of 12 years’ experience required, preferably in a design and product development environment.
2-4 years of management experience
Six Sigma experience, CQE/CQM/PE certification preferred. Formal training in Quality Systems.
Must be able to communicate with large groups of people.
Must be able to review printed materials.
Must be able to generate and explain detailed proposals, guidelines, and procedures for the Quality function to departmental and/or non-departmental personnel.
Must be able to analyze and resolve non-routine product issues using independent judgment.
Must be able to routinely make decisions which affect immediate operations and may have a company-wide effect.
Must be able to observe and correct minute inconsistencies (e.g., in the printed word, a production process, product appearance, etc.).
Excellent analytical, interpersonal, and organizational skills with demonstrated ability to effectively manage others.
This is a leadership position that contributes and achieves results through others. The role is responsible for managing subordinates in professional jobs or managing through subordinate managers / supervisors or is a leader of process that achieves results through others, who are not direct reports. Job requires a broad and comprehensive understanding in multiple disciplines relevant to the business. The job is expected to establish strategic plans and/or operational programs that require a sound understanding of the underlying theories underpinning the subject area. The job has full management responsibility including the management of numerous teams of managers/professionals, planning for the teams' future needs and operations. There will be financial accountability for independent budgets.
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.
The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.
More information is available at stryker.com (http://www.stryker.com.)
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.