Staff Specialist, Quality Management Systems in Portage, MI at Stryker Corporation

Date Posted: 2/1/2020

Job Snapshot

Job Description

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Staff Specialist, Quality Management Systems located in Kalamazoo Michigan

Who we want:

Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.

Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

User-focused creators. People who imagine with the user in mind, developing technology that helps change patients’ lives.

What you will do:

  • Analyze, administer and implement programs to establish and maintain quality standards of existing products and services, as well as developing programs to focus employees on quality improvement.
  • Develops policies, procedures and methods to check product, material, components and/or operational quality and improve same.
  • Develops policies, procedures and methods to evaluate and improve the quality of products, materials, components and/or operations.
  • Develops, assures and maintains the quality of products and processes, including standard procedures (e.g., ISO 9001:2000, ISO 14000 family of standards), quality audits/review, Taguchi methods, process reengineering, etc.
  • This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision.
  • As a leader in the Quality Systems area, collaborates with the global Instruments Organization and Corporate teams on behalf of Quality Systems and Quality System issues.
  • Helps to set the direction of the department and should serve as a process owner. Leads special initiatives and helps to direct other Quality Systems personnel.
  • Participating in internal and external audits.
  • May perform in the NC CAPA process.
  • Develops, edits, and maintains Quality System Documentation to support Division Quality System Management processes, which includes: Organizing and implementing Quality Agreements and process ownership of QAs.
  • Working on cross-functional teams and collaborating with partners in the Organization to document process expectations in Quality Agreements.
  • Preparing updates to documentation because of improvements to processes or changes to regulations/standards.
  • Coordinating documentation changes with impacted sites, including acquisitions, to ensure accuracy.
  • Implementation of Corporate and Instruments QMS into acquisition Quality System.
  • Provide oversite or QS regulations and standards for gap assessments and implementation globally, including acquisition sites.
  • Influences positive Quality System outcomes across the global Division by: Helping POs and SMEs navigate the Quality Agreements and addendums. Promoting improvements to processes, where necessary.
  • Building strong relationships with POs, SMEs, and partners at all sites in scope of Instruments products and service needs.
  • Emphasizing the importance of adhering to good documentation practices.
  • Supports effective and efficient Quality System Training by: Working with Corporate Quality System partners to keep current with regulatory/standards expectations.
  • Coordinating role and training updates with QS training partners, POs, and SMEs.
  • Assisting with efforts to streamline training and to deliver engaging training to end users.
  • Creating training materials for quality system changes, including test materials, where applicable.
  • Acquires subject knowledge by interviewing product engineers, regulatory, quality, marketing personnel, or other team members to ensure documentation reflects actual process state.
  • Develops or supports the development of descriptions of change to use for communicating changes to Quality System documentation.
  • May take on special assignments to further department or Division initiatives.
  • Completes all projects within the established schedules.

What you need:

  • Bachelor’s Degree with a minimum 5 years related experience
  • Must possess strong communication, project management and influencing skills as well as successfully manage multiple tasks simultaneously.
  • Demonstrated knowledge of U.S. Food and Drug regulations, as well as of European and international regulatory/industry guidelines/standards, and ability to interpret and apply is preferred.
  • Excellent communication, time management, and organization skills with high emphasis on attention to detail.
  • Experience in working on multi-disciplinary teams
  • Ability to successfully interface with various departments and personnel
  • Ability to work independently and motivated to perform at a high-level without constant supervision
  • Ability to handle multiple projects on an ongoing basis
  • Ability to adhere to necessary processes within a regulated environment

Work From Home: No

Travel Percentage: 10%

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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