Principal Quality Systems Specialist

Stryker Corporation Redmond , WA 98053

Posted 6 days ago

Job Description:

It's time to join Stryker!

We are a great place to work. Fortune, in association with Great Place to Work, named us among the World's Best Workplaces. We ranked #10 out of the 25 companies on the list. This list highlights companies that have gone above and beyond to create a great workplace for employees all over the world. Fortune also named us one of the 100 Best Companies to Work For in the United States. This is the seventh consecutive year we have been on the list, and we ranked 16 out of 100.

We aspire to create a place where hard work, humility, honesty, a sense of service and humor are the talk we walk. We are a very diverse group with an amazing set of experiences from bio-tech and high-tech companies. If that doesn't pique your interest, we've got scientists, motorcycle racers, some serious sailors, biking enthusiasts, whiteboard artists, videographers, mountain climbers, parents, triathletes, dog owners, avid runners, skiers and snowboarders. And we're always looking for players for our "awful"-ly fun summer volleyball tournament.

We combine laughter with intensity and focus. We have fantastic office space in the amazing Redmond-Woodinville Valley (yes, free parking), down the street from "Washington Wine Country". We pay competitively, and offer full benefits to our Team Members.

In this role you will:

Be primarily responsible for the strategic development of the quality management system in accordance with relevant regulatory requirements for medical devices. Oversee and ensure that an effective and efficient quality management system is built and maintained while providing technical leadership on a regional and global level. Responsibility for ensuring that all applicable quality system regulations are met in order to receive regulatory clearance/certification.

What You Will Do

  • Ensure QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, MDD, and individual country requirements).

  • Ensure optimum state of QMS for current and future business needs.

  • Provide guidance to identify and deliver strategic and futuristic improvements and inputs into the quality planning process.

  • Drive development and/or modification of Stryker's QMS.

  • Oversee and/or manage Management Review and Quality Planning Review and related forums.

  • Assess and quantify requirements for QMS requirements to optimize structure.

  • Ensure GMP and GDP compliance within Quality organization. Monitor changes in regulatory requirements.

  • Oversee identification and implementation of improvement opportunities to increase the efficiency and effectiveness of the QMS.

  • Liaise with global and corporate partners to provide best-in-class global solutions and input into processes.

  • Ensure development and delivery of training for QMS areas of expertise.

  • Responsible for the development, maintenance, and improvement of policies and procedures.

  • Liaise with notified bodies to manage certification changes.

  • Ensure QMS reflects actual activities, business needs and supports NPD requirements.

  • Manage QMS activities to support achievement of project milestones.

  • Provide direction for the overall QMS strategy. Lead improvement processes, executing and leading projects.

  • Understand and contribute to the development and generation of IS compliance and validation documentation.

  • Owner of QMS business process(as) and understanding of IS system support requirements.

  • Oversee internal audit program.

  • Represent expertise during internal and external quality system audits.

  • Strong knowledge of system integration.

  • Assess and approve IS change control assessment and approval.

What you Need

  • Bachelors Degree

  • Minimum of 9 years experience in quality or manufacturing environment

What We Would Really Like You To have :

  • Bachelors Degree in a science, engineering, business or related discipline, or equivalent combination of education and experience

  • Experience in regulated environment and interaction with regulatory agencies

  • Thorough knowledge and understanding of US and International Medical Device Regulations.

  • Strong knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)

  • Demonstrated ability to develop and implement global strategies. Initiates, sponsors, and implements changes with a demonstrated track record.

  • Expert working knowledge of regulatory requirements, standards, and regulations with significant audit experience.

  • Strong communication, project management and influencing skills.

  • Ability to plan, organize, and implement multiple concurrent tasks.

  • Strong interpersonal skills, written, oral communication and negotiations skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.

  • Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.

  • Demonstrated ability to work in cross-functional team environments.

  • Demonstrated ability to make timely and sound decisions through effective approaches for choosing a course of action or developing appropriate solutions.

  • Builds strong relationships by fostering open communication, respect and trust.

  • Act with a customer service/stakeholder-focused approach.

  • Leverages excellent interpersonal keys to achieve desired outcomes.

  • Presents as a change agent by adopting a continuous improvement orientation.

  • Act as the voice of Quality in cross-functional teams, ensuring appropriate outcomes.

  • Computer literacy.

Things To Consider:

  • Minimal travel (<10% may="" be="">

  • Fast-paced office environment requiring significant use of standard office equipment including computer keyboard, monitor, and mouse, and telephone.

  • May require long hours during peak project and/or audit periods.

Work From Home: Yes

Travel Percentage: Up to 25%

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.


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