Senior Staff RAQA Systems Specialist in Portage, MI at Stryker Corporation

发布日期: 1/13/2020



Who we want

  • Self-directed innovators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

What you will do

As a Sr. Staff RAQA Systems Specialist you will be responsible for the deployment and sustainment of regulatory and quality processes within a new ERP platform across the Stryker Medical division. You will ensure that processes satisfy quality management requirements, are documented in quality systems, define continuous improvement activity and comply with all regulations and standards. 

  • Serve as the primary contact for a new divisional ERP Program and RAQA team
  • This role is accountable for the successful deployment of RAQA related areas within the ERP system. Focusing on efficient, effective and compliant practices ensuring that no new compliance risks are introduced.
  • As the RAQA divisional lead you will work with subject matter experts in areas such as Service Complaint Handling, Batch and Serial Number Management, Execution of Product Holds and PFAs, RAQA-related aspects of Product Introduction and Phase Out and Product Registration.
  • Engage and coordinate with campus-level leads to define any unique user needs as we move from current to future states in a new ERP system.
  • Work with all sites to solidify plans to adapt and incrementally adjust local QMS procedures and adjacent QMS processes to lead to a successful launch of ERP.
  • Identify and Communicate to Program Stakeholders within RAQA on the status, risks and dependencies of the Program as it relates to RAQA.
  • Engage Divisional and Site Process Owners for input as well as engaging them in the definition of new/changes to current procedures and training materials.
  • Build, Deploy and Sustain training curricula for RAQA-related elements.
  • Build capabilities within local sites and DPOs, with the goal that they can serve as SMEs within the ERP platform for RAQA-related areas.
  • Prepares new acquisitions for the RAQA-related implementation of ERP and as these areas tie into TrackWise and other related systems.
  • Monitors changes to Corporate-Level Quality Procedures, FDA (and other) and other Quality System Regulations or Standards and serves to sustain RAQA elements of ERP after implementation as new regulatory or quality needs are identified.
  • Reviews progress with management and stakeholders, escalating any issues or gaps for resolution.  May direct priorities among RA/QA Heads at other sites.

What you need

  • Bachelors Degree in Engineering or related field
  • 5 Years of exp
  • Prior experience across the Medical Device Quality System, with a focus on traceability, packaging, field actions and holds as well as adjacent areas such as Complaint Handling, Design & Development, Change Control and Document Control highly preferred

Work From Home: Occasional

Travel Percentage: 30%

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.