**Basic Function:** + Responsible for developing, applying, revising, and maintaining quality system and subsystems. **Responsibilities:** + Comply with all regulatory and quality systems standard requirements. + Responsible to stop further processing in the event of encountering non-conforming product condition. + Analyzes reports and/or returned products and recommends corrective action. + Designs and implements methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and/or production and/or test equipment. + Implement effective process controls at Stryker Puerto Rico and or supplier’s facilities. + Validate internal and/or supplier processes and products. + Verify completeness of specifications of Stryker Puerto Rico products and/or processes. + Audit internal and/or supplier products and processes. + Active participation in external audits to SPR. + Provide engineering interface with manufacturing and quality engineers in Stryker Puerto Rico. + May work from verbal and/or written instructions. + May train other in Quality Assurance/FDA-QSR related topics. + Prepare Quality Plan per Quality System requirements for Processes, Projects and New Products/Line Extensions. **Supervisory Responsibilities:** + May coordinate and evaluate the activities of one or more non exempt employees. + May coordinate and evaluate the activities of one or more exempt employees when leading a project team. + May provide expert advice or mentoring to professionals at different levels. **Physical Requirements:** + Sedentary Work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, etc. generally involves sitting most of the time. + Very good visual acuity. + The ability to work with and inspect very small objects and/or tools and component parts. **Mental Requirements:** + Must be able to observe and note minute inconsistencies. + Must be able to generate, follow, and explain detailed instructions and inspection procedures. + Must be able to complete detailed documentation accurately. + Must be able to communicate product and/or component part deficiencies to engineers, subordinate, or supervisory personnel. + Must be able to analyze and resolve non-routine product issues using independent judgment and inspection equipment. **Required Skills:** + Strong analytical skills. + Effective interpersonal skills. + Blueprint/Engineering schematic reading and interpretation. + Basic inspection techniques. + Basic computer skills. + Strong knowledge in Validation per FDA-QSR and ISO guidelines. + Strong Statistical Knowledge (SPC, DOE, CPk, etc). + Technical writing skills. + Fully bilingual (English and Spanish). + Problem solving and decision making skills. **Required Experience:** + 10-12 years minimum in Quality Assurance or related functional area. + Knowledge of inspection methods in the design and production of electro-mechanical and/or mechanical equipment. **Required Education and Training:** + B.S. in Engineering or Engineering related discipline. + Formal Quality Assurance Training. + ASQ – CQE or CQA Desired. 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.