Arroyo, PR, 00714, USA
1 day ago
Quality Engineer
The following is not intended to represent an all inclusive list of job responsibilities, but to outline the ESSENTIAL FUNCTIONS of the position. Basic Function: + Responsible for developing, applying, revising, and maintaining quality standards for processing raw materials and/or components into partially finished and/or finished products. Responsibilities: + Continuously comply with all regulatory related requirements. + Will conduct Internal and External audits. May train others in Quality Assurance/GMP/FDA-QSR related topics. + Design and/or implement methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and/or production and/or test equipment: Statistical process control, Incoming part/product inspection criteria, Automated testing, Functional gauging, Productivity improvements + Stop further processing in the event of encountering non-conforming products condition. + May design and/or specify inspection and testing mechanisms and equipment. + Prepare documentation for inspection/testing procedures. + May support vendor management issues: Problem solving, Auditing, Inspection techniques/equipment, Training. + May interact with suppliers either telephonically or in person to develop and standardize inspection methods and or techniques to ensure components compliance with specifications. + May interact with customers either telephonically or in person to solve reliability issues and/or answer general product questions. Complaint investigation/problem solving, Customer training, Design improvements and Special Orders. + May assist during new product development. Validation support for product, processes, packaging, software, and sterilization. + Analyze reports and/or returned products and recommends corrective action. Will conduct failure analysis of products and processes: Problem solving efforts, Reliability design improvements, Product failure trending, Training. + May work from verbal and/or written instructions. + Commit to the EHS policy. Supervisory Responsibilities: + May coordinate the activities of one or more Quality Control Inspectors and/or Technicians. + May evaluate the performance of one or more Quality Control Inspectors and/or Technicians based on pre-established performance parameters. Physical Requirements: + Sedentary Work: Exerting up to 10 lbs. 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: + Observe and note minute inconsistencies. + Generate, follow, and explain detailed instructions and inspection procedures. + Complete detailed documentation accurately. + Communicate product and/or component part deficiencies to Engineer, subordinate, or supervisory personnel. + Analyze and resolve non-routine product issues using independent judgement and inspection equipment. Required Skills: + Strong analytical skills + Effective interpersonal skills + Blueprint/engineering schematic reading and interpretation + Basic inspection techniques + Basic PC skills + Bilingual (English and Spanish) Required Experience: + 0 to 2 years in Quality Assurance or related functional area + Some knowledge of inspection methods in the design and production of electromechanical and/or mechanical equipment. Required Education and Training: + B.S. in engineering or engineering related discipline. + Licensed Engineer (EIT or PE) desired + Some Quality Assurance training 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.
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