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Cary, North Carolina, United States
Hybrid
Stryker is hiring a Staff Quality Systems Specialist for our Medical division supporting our Stryker Sage business unit in Cary, IL who will be responsible for the development of the quality management system in accordance with relevant regulatory requirements for medical devices, drugs, and cosmetics. The Quality Systems Specialist will oversee, support, and ensure that an effective and efficient quality management system is built and maintained. Responsibility for ensuring that all applicable quality system regulations are met to receive regulatory clearance/certification.
Workplace Flexibility: Hybrid work schedule with three onsite days (Monday, Tuesday, and Wednesday) and the option to work remotely on Thursday and Friday. Candidates must reside within a reasonable commuting distance of Cary, IL to support regular onsite collaboration and business needs.
What you will do:
Ensure compliance with applicable regulatory and quality standards, including FDA, ISO 13485, MDR, GMP, GDP, and corporate requirements.
Lead the development, implementation, and continuous improvement of Quality Systems to support business objectives and regulatory compliance.
Serve as a subject matter expert and process owner for assigned Quality Management System (QMS) processes.
Identify, evaluate, and implement process improvements to enhance Quality System effectiveness, efficiency, and inspection readiness.
Develop, maintain, and improve quality policies, procedures, and documentation to support operational and regulatory requirements.
Lead Quality Systems initiatives and cross-functional projects, applying project management principles to achieve key milestones and deliverables.
Support internal and external audits, regulatory inspections, and certification activities, including interactions with notified bodies and audit response activities.
Develop and deliver training, provide guidance to stakeholders, and promote Quality Systems best practices across the organization.
What you need:
Required:
Bachelor's degree in Science, Engineering, Business, Quality, or a related discipline.
Minimum of 4 years of experience supporting Quality Systems within a regulated industry (e.g., medical device, pharmaceutical, biotechnology, cosmetics, manufacturing, aerospace, or other regulated environments).
Experience developing, implementing, maintaining, and/or continuously improving Quality Management System (QMS) processes, procedures, and documentation.
Working knowledge of core Quality Systems elements such as document control, change management, risk management, validation, or design controls.
Experience supporting compliance activities, identifying quality or compliance risks, and driving appropriate documentation, escalation, and resolution.
Preferred:
Experience participating in Quality System integration, harmonization, merger, acquisition, or transformation initiatives across sites, business units, or organizations.
Strong technical writing and documentation experience, including development or standardization of procedures, work instructions, quality records, validation documentation, or integration plans.
$91,600 - $152,700 USD Annual
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.