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Senior Quality Engineer, New Product Introduction
- Stryker (Arroyo, PR)
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What you will do:
+ Support the design and testing of new products.
+ Ensure that everything functions well and meets quality standards.
+ Identify and prevent potential problems (especially risks, defects, and inspection issues).
+ Ensure the product can be manufactured efficiently and safely.
+ Support validations (process, tool, and equipment testing).
+ Assist in the selection and approval of suppliers for new components or processes.
+ Lead quality activities during design transfer (when the product moves from design to production).
+ Work closely with engineering and manufacturing teams to ensure product quality and manufacturability.
What you will need:
Required:
+ University degree in engineering (or similar).
+ At least 2 years of experience in regulated industries, such as medical devices or pharmaceuticals.
+ Understanding of manufacturing processes and quality tools such as FMEA (Failure Mode and Effects Analysis), CAPA (Corrective and Preventive Actions), PPAP (Production Part Approval Process), validations, and inspections.
+ Knowledge of standards such as ISO 13485 (quality standard for medical devices).
+ Advanced English communication skills (oral and written).
Desirable:
+ Experience with Process Flow Mapping (PFM) or process risk assessment.
+ Experience with non-conformity management.
+ Experience with supplier quality initiatives.
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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Senior Quality Engineer, New Product Introduction
- Stryker (Arroyo, PR)