**Stryker** is hiring a **Senior CAPA Specialist** in **Portage, MI** within the **Instruments division** ! In this role, you’ll lead the execution of the Divisional Nonconformance (NC) and Corrective and Preventive Action (CAPA) processes, ensuring quality issues are addressed effectively and in compliance with global standards. Leveraging your expertise in problem-solving methodologies, you’ll help drive proactive issue resolution and continuous improvement across the organization. **Workplace Flexibility** : Candidate must reside within a commutable distance to **Portage, MI** but is expected to be onsite at the facility multiple times/week. **What you will do-** + Support post-market quality activities by reviewing and approving Nonconformances (NCs) and Corrective and Preventive Actions (CAPAs) for completeness, accuracy, and compliance with FDA, ISO 13485, and global regulatory standards. + Assist in developing and delivering training for CAPA users, promoting understanding of system requirements, problem-solving methodologies (e.g., 4D), and best practices. + Collaborate with cross-functional teams to resolve quality issues, integrate processes from acquisitions, and maintain documentation such as business process maps and SOPs. + Contribute to continuous improvement initiatives by assessing NC/CAPA records, identifying trends, and supporting enhancements to procedures and systems. + Participate in internal, corporate, and external audits by preparing documentation and supporting discussions related to NC/CAPA processes and records. + Monitor and present NC/CAPA metrics to leadership, helping drive achievement of key performance indicators (KPIs) and process effectiveness. + Facilitate CAPA boards and specialist meetings, supporting alignment across departments and ensuring timely and rigorous documentation in the eCAPA system. + Act as a resource for CAPA record owners and stakeholders, providing guidance on regulatory expectations, documentation standards, and system navigation. **What you need:** _Required:_ + Bachelor’s degree in a Science or Engineering required. + Minimum 2 years of experience in quality systems or engineering, with exposure to CAPA processes and supporting quality system elements such as audits, management review, and quality planning. + Experience working in regulated environments and supporting interactions with regulatory agencies (e.g., FDA, TUV, BSI) required. _Preferred:_ + Working knowledge of U.S. FDA regulations and international standards (e.g., ISO 13485, EU MDR), with the ability to interpret and apply regulatory requirements in a practical setting. 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.