Principal Specialist, Quality Systems in Portage, MI at Stryker Corporation

Date Posted: 8/1/2018

Job Snapshot

  • Employee Type:
  • Location:
    Portage, MI
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

Who We Want:

Our team in Portage MI is looking for a quality systems specialist with exceptional customer service and attention to detail.  As a team we work to make sure the job is done right, every time.  If you have a passion for quality, data management, and electronic systems, this is the job for you!

What You Will Do:

As a Principal Specialist, Quality Systems you will be responsible for the strategic development of the quality management system in accordance with relevant regulatory requirements for medical devices on a regional and global level.

You will oversee and ensure that an effective and efficient quality management system is built. You will support the establishment, implementation, and maintenance of Global Regulatory and Quality processes, documents, and systems supporting our Global QMS, specifically related to PLM systems and data management of UDI systems.

  • Ensure QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, MDD, MDR, and individual country requirements).
  • Ensure optimum state of enterprise systems for current and future business needs and ensure enterprise systems reflect actual activities that meet the needs of global users.
  • Ensure GMP and GDP compliance within Quality organization.
  • Oversee identification and implementation of improvement opportunities to increase the efficiency and effectiveness of enterprise systems.
  • Liaise with global and corporate partners to provide best-in-class global solutions, training and processes.
  • Responsible for the development, maintenance, and improvement of policies and procedures.
  • Ensure enterprise systems reflect actual activities and business needs and supports NPD requirements.
  • Provide expertise during internal and external quality system audits as needed.
  • Understand IS system support requirements and contribute to the development and generation of IS compliance, integration and validation documentation.
  • Updates Global Governance, RA/QA Leadership, and PMO on direction and progress.
  • Ensures global initiatives are communicated and understood by stakeholders.
  • Participates in meetings, surveys, information-gathering, and global decisions for geographically dispersed teams.
  • Serve as Subject Matter Expert and manage day-to-day quality processes, specifically related to PLM systems and data management of UDI systems.
  • Manage and provide updates for quality metrics

What You Need:

  • BS in a science, engineering, business, or related discipline.
  • 9+ years of experience in manufacturing environment or equivalent preferred.
  • Experience in regulated environment and interaction with regulatory agencies required.
  • Prior cross-site/division experience desired.
  • Thorough knowledge and understanding of US and International Medical Device Regulations, and strong knowledge of Quality Systems.
  • Expert working knowledge of regulatory requirements, standards, and regulations with significant audit experience.
  • Analytical ability to draw insights from data and define executable actions.
  • Builds strong relationships by fostering open communication, respect, and trust.
  • Subject matter expert for the regulatory and Stryker business requirements of their area of expertise, specifically related to PLM systems and data management of UDI systems.
  • Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements.

Work From Home: No

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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