**Job Summary:** The Staff Quality Management Systems – Standards & Compliance role is responsible for overseeing and coordinating the external document process, ensuring that changes to standards, regulations, and related materials are properly reviewed, assessed, and integrated into internal quality management systems. This individual contributor position plays a key role in evaluating the impact of external changes on internal procedures, policies, and specifications. The ideal candidate will exercise sound professional judgment, apply specialized expertise, and work independently to ensure compliance, identify risks, and recommend quality assurance strategies across the organization. **Job Description:** We are seeking a knowledgeable and detail-oriented quality professional to join our Standards and Compliance team as a Staff Quality Management Systems specialist. In this role, you will coordinate and support the external document process, ensuring timely review and integration of external standards, regulations, and industry documents that may impact internal procedures, specifications, and quality policies. As an expert in quality systems and regulatory compliance, you will collaborate with teams such as Regulatory Affairs, Design Assurance Engineering, and Global Quality Operations to evaluate impacts and ensure compliance. You will present external document status and SME assessments to the External Document Review Board (EDRB) to support decisions on integrating changes into internal quality management systems. This position demands independent judgment, deep technical knowledge, and a proactive mindset to maintain and enhance quality system performance. Key Responsibilities: + Oversee and coordinate the external document control process for monitoring and reviewing regulatory standards and industry guidelines. + Evaluate external documents for potential impacts on internal quality procedures, specifications, and policies. + Collaborate with cross-functional stakeholders to assess risks, determine actions, implement changes and document decisions. + Present external document status and SME assessments to the External Document Review Board (EDRB) to support decisions on integrating changes into internal quality management systems. + Develop and implement quality assurance strategies to ensure adherence to applicable regulations and standards. + Provide recommendations to maintain and improve quality system effectiveness. + Ensure quality control processes are in place and followed throughout the document management lifecycle. + Administer and enhance processes for establishing and maintaining quality standards and continuous improvement initiatives. + Analyze regulatory trends and provide subject matter expertise to relevant teams. + Serve as the point of contact for audits and inspections related to external document control and compliance. + Track assessments, monitor key metrics, and report progress and outcomes to stakeholders. + Work independently with minimal supervision, exercising sound judgment based on professional knowledge and experience Required Qualifications: + Bachelor’s degree or higher. + Minimum of 4 years of experience in a regulated industry (e.g., medical devices, pharmaceuticals, or other life sciences sectors). + Experience working with standards and regulations, for example: + FDA Quality System Regulation (21 CFR Part 820) + FDA Enforcement Policy (21 CFR Part 7) + ISO 13485 Quality Management System + European Medical Device Directive (MDD) or Medical Device Regulation (MDR) + Canadian Medical Device Regulations (CMDR) + Strong communication skills, both written and verbal. + Effective presentation abilities to clearly convey information to diverse audiences. + Proven team player with the ability to collaborate across functions and cultures. Preferred Qualifications: + Bachelor’s degree in a science-related discipline + Over 4 years of experience specifically in regulatory compliance within medical devices, pharmaceuticals, or other regulated industries, including hands-on experience in developing, implementing, and administering quality processes and procedures. + Demonstrated ability to lead and collaborate with cross-functional and multi-national teams, ensuring alignment with regulatory and internal quality requirements. + Proven success in managing complex projects, effectively prioritizing tasks, and meeting deadlines in high-paced environments. + Strong track record of achieving objectives with minimal supervision. + Proficiency in Microsoft Office Suite, including Outlook, Word, Excel, and PowerPoint. + Data analytic skills a plus, including the ability to interpret and communicate data-driven insights to support quality and compliance decisions. Travel Percentage: 10% Insert detailed job description here. Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role. 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.