Job Information
Stryker Director Quality Assurance in Portage, Michigan
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Essential Duties and Responsibilities
Manages directly and/or through subordinate supervisors the activities of the Instruments AQE functions. Directs teams responsible for NPD development to fulfill all Stryker Design Controls quality requirements and external regulatory requirements for product launch. Includes fulfillment of customer quality metrics for launch and PLFU completion.
Provides global support to all Instruments sites in support of NPD. Builds and executes strategy for innovation, growth, and technical expertise of the Global AQE function. Provides direct and indirect mentorship and support to global Instruments AQE leadership.
Develops and drives a highly compliant, quality culture that enhances NPD efficiency and on-time delivery of projects through proactive quality engineering solutions and strong relationships with NPD functional leaders.
Works cross functionally across multiple functional areas, including R&D, AO, Clinical, RA, Marketing, PMO, and GQO to execute NPD strategy.
Acts as Quality leader to review, support, and approve design and development plans including evaluation and approval of deviations as required.
Acts as Quality leader for NPD steering teams providing input to optimize time, cost, and quality objectives while ensuring appropriate resource planning and allocation to meet project goals.
Responsible for Reliability Engineering for the Division, providing resources and guiding Reliability Engineering best practices to NPD as well as managing the Highly Accelerated Life Test chamber testing.
Acts as Division Process Owner (DPO) for the Risk Management process with direct or indirect leadership of Risk SMEs for global Instruments, including acting as Risk SME for the Risk Management Board (RMB) and Product Field Action (PFA) processes.
Provides direction and support to complete M&A Integration activities. Will be responsible for overall RAQAC integration leadership for a given integration, depending on need and subject matter expertise.
Supports process validation program. Will review and or approve change control & validation plans, documentation and specifications.
Will oversee and/or be involved in training others on QA topics.
Sets overall departmental goals and priorities and evaluates subordinate’s performance against those goals and priorities.
Coaches and develops direct and departmental subordinates. Responsible for professional development and training of department to ensure high technical competency and applying state of the art engineering concepts in a compliant manner.
Responsible for departmental compliance with company policies
Responsible for departmental budget.
Provides indirect support and mentorship to other RAQA leaders throughout Stryker Corporation through professional relationships and Corporate programs and initiatives.
Supports external audits through leadership roles and presents processes (e.g. Risk, Design Controls) and records such as DHFs and RMFs as required.
Maintains strong expertise in all QMS processes to guide NPD teams in an effective, efficient, and compliant manner.
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.