仕事内容

Who we want

• Self-directed imitators. 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 Senior Staff Quality Systems Specialist, you will lead the Integration and Sustainment of Complaint Handling as a Divisional Process Owner. You will serve as subject matter expert for our organization to build understanding of quality concepts and drive our quality culture across newly acquired sites.

• Build capabilities within local sites, with the goal that they can serve as a divisional process owner for Complaint Handling for Medical Device, Pharmaceutical, Biocides and Cosmetic Products across the Medical division for key areas, such as:
  • Complaint Intake
  • Complaint Handling
  • Setting and performing against complaint metrics
  • Leading site process owners in process and regulation changes
  • Drive continuous improvement to the Complaint Handling processes.
• Represent the Medical Division on the Global Complaint Handling hub and spoke team to establish, implement, and maintain global Regulatory and Quality processes, documents, and systems supporting Stryker’s Global QMS
  • Coordinate input, feedback, and represent Medical Division’s needs on the global hub & spoke team
  • Accountable for local process/system/training implementation
• Provide input and prepare new acquisitions under Stryker Medical for the implementation of TrackWise as the software tool which is used to manage complaints electronically.
  • Support sites in the understanding of Complaint Handling in TrackWise
  • Work with sites to understand their plans to adapt and incrementally adjust local processes to lead to a successful new Complaing Handling adoption in TrackWise
  • Develop a plan to support sites in the TrackWise system
  • Facilitate recurring meetings with Complaint Handling site process owners, subject matter experts and management at sites within the Medical division to identify best practices and build a community of experts in this area.
• Connect with other Medical divisional process owners to integrate and improve connections to adjacent processes, as needed, to support the Complaint Handling process:
• Lead the representation of Quality Systems and Quality Processes which you own in External Audits and/or support local site process owners.
• Monitor compliance to Corporate Quality Procedures, FDA (and other) Quality System Regulations (QSR’s) and update as necessary

What you need

• Bachelor’s Degree – Engineering preferred or related field
• Minimum of 7 years of experience in Quality Systems or Quality Engineering.
• Experience 21 CFR Part 820, ISO-13485, EU MDR, MDSAP, and preferably training for ISO-14971, strongly preferred not required.
• Breadth of knowledge across the Medical Device Quality System, with a focus on pre and post-market activities (e.g., Complaint Handling, Design & Development, Risk Management, Change Control, Document Control, Quality Planning) preferred not required
• Manage projects in a timely manner, including ability to accurately assess resources, time and systems necessary to complete a project preferred not required
• Project Management training and/or experience preferred not required

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.