Stryker is hiring a Quality System Specialist for our Medical Division in Kalamazoo, MI where you will be an integral part of the diverse and dynamic Quality Systems team. This role will support various quality management system (QMS) processes like Training, QMS Document Change Management, Record Retention, and Internal Quality Agreements. This involves working closely with the Site Process Owners (SPO) for these processes to sustain the day-to-day activities, drive engagement and continuous improvements.
Work Flexibility: Hybrid; Candidate must reside within a commutable distance to Kalamazoo, Michigan but is expected to be onsite at the facility at least 3 days/week (Monday, Tuesday & Wednesday) with optional remote flexibility on Thursday and Fridays. This is based on the business need at the time.
What you will do:
Assist subject matter experts, document owners, and process owners to support document change orders including initiating, launching, tracking, and implementing in PLM systems.
Support/assist the record retention process, including relationship with 3rd party document storage facility through document storage/retrieval and ensure invoicing accuracy
Support creation, approval, and management of internal quality agreements including periodic reviews, updates, and approvals
Monitor training assignments and metrics for process compliance.
Serve as the Stryker Learning Management System (SLMS) expert to address stakeholder training requests.
Support process owners to ensure QMS processes align with FDA, ISO, and various international standards and regulations.
Drive continuous improvement initiatives through audit findings and compliance gaps.
Maintain a state of audit readiness (prep and ongoing compliance).
What you need:
Required:
Bachelor’s degree or higher with no prior work experience necessary.
Preferred:
1–2 years of experience in a regulated industry within a Regulatory Affairs, Quality Assurance, or Quality Control role, with demonstrated proficiency in adhering to QMS processes.
Must possess high level knowledge of MS Office applications
Basic knowledge of quality management systems as it relates to FDA, ISO 13485:2016, MDSAP, and other international regulations
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.