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    Director of Quality - San Jose, United States - Stryker Group LLC

    Stryker Group LLC
    Stryker Group LLC San Jose, United States

    4 weeks ago

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    Description
    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 withotherincredibly talented and intelligentpeople, 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:

    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


    Essential Functions:
    Responsible for new product development (design) quality as well as post market (customer) quality

    Provide a strategic direction and tactical focus to the Quality Engineering organization and influence the direction of business unit product Quality and Design Assurance activities.

    Responsible for establishing metrics/KPIs for quality
    Capable of leading a team of engineers to deliver relentless product quality improvements in post market and support customers/field teams with a sense of urgency
    Conducts periodic Quality review with senior leadership within the division and responsible for providing data /state of affairs of product quality in the field
    Actively involved in new product design and development teams to launch new products with high quality that meet user needs (including safety, reliability etc.)
    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.
    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.
    Maintains and manages cost centers for team
    Leverages relationships with cross functional leaders within business unit to set and achieve key product quality goals
    Responsible for supporting complaint handling, MDR-MDV reporting and product field action decisions.
    Participates and provides support during FDA and regulatory audits

    Ensure that manufacturing, product development, and related functions are conducted in compliance with international standards and government regulations in support of company mission.

    Chair meetings required to drive closure of quality issues.
    Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets.
    Recruit, select, and on-board top talent as well as improve team capability, impact (ROI) year over year
    Develop talent within team to increase performance. Actively address performance issues on team.
    Maintain a high level of team engagement.
    Travel up to 30%

    QUALIFICATIONS:
    This is a management 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, whom 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.
    Minimum of 12 years experience in a design and product development environment preferably in Medical Device industry
    Minimum 4+ years of management experience
    BS in Engineering or other relevant field of study.
    Master's Degree or equivalent preferred.
    Six Sigma experience, CQE/CQM/PE certification preferred.
    Must be able to communicate with and inspire large groups of people.
    Must be able to review technical documentation

    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 inconsistencies across business/team
    Excellent analytical and root-cause skills.
    Excellent interpersonal skills.
    Demonstrated effective managerial skills.
    Excellent organizational skills.
    Comfortable putting together presentations frequently and presenting to senior leadership
    Comfortable communicating with customers and field teams
    Highly accountable for results
    $184,000 - $311,700 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.

    About Stryker

    Our benefits:

    12 paid holidays annually

    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.

    For a more detailed overview of our benefits or time off, please follow this linkto learn more: US Stryker employee benefits

    About Stryker

    Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better.

    The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes.

    Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at

    Know someone at Stryker?
    Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program on our referral page

    Stryker is driven to work together with our customers to make healthcare better.

    Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.

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