Quality Engineer, New Products Introduction

hace 2 semanas

Tijuana, México Stryker A tiempo completo

**Why engineering at Stryker?****:
At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.

**Who We Want**
- ** Detail-oriented process improvers.** Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.
- ** Self-directed imitators.** People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
- ** Collaborative partners.** People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
- ** Analytical problem solvers.** People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
- ** Goal-oriented developers.** Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

**What You Will Do**

Responsible for the identification of potential failure modes and risks, and the development of quality assurance practices and controls in multiple new product developments and/or manufacturing transfers. Knows and applies the fundamental and some advanced concepts, practices, and procedures of the new product introduction quality specialization. Support the required stages defined in the product and process design cycle ensuring compliance with the current design control and transfer regulations and policy.
- Essential Duties & Responsibilities:_
- Responsible for the evaluation of process risks, risk mitigation and ensures appropriate production and process controls are identified, qualified, and implemented throughout the product manufacturing lifecycle (from incoming of materials/components, manufacturing, until product release).
- Implement internal detective process controls.
- Specify which preventative and detective controls are required, and communicate to vendors, internal/ external clients.
- Verify gage repeatability, reproducibility, and accuracy, and address deficiencies on inspection methods.
- Support the development of inspection methods.
- Validate inspection methods and ensure methods between supplier and Stryker correlate accordingly.
- Ensure potential process failures are reproduced and/or tested to evaluate internal and external impact.
- Support the identification of new suppliers and supplier development activities to ensure compliance and business continuity.
- Lead supplier component qualifications through Production Part Approval Process (PPAP) and ensure appropriate controls are placed at the suppliers to ensure and verify components quality.
- Collaborates with Staff Engineer in all process validation activities to ensure consistent, repeatable, and effective processes are implemented during design/manufacturing transfer.
- Develop a validation strategy.
- Develop statistical rationale for testing.
- Develop the rationale for validation sample size, duration, and number of runs.
- Ensure worst-case scenarios are challenged during the process development and/or validation.
- Eliminate waste from the processes (i.e. scrap, rework, wait times, etc).
- Execute performance qualification activities for new process.
- Develops sterilization validation strategies with Subject Matter Experts and is responsible to execute and document such validation activities.
- Continuously fully comply with all quality regulatory requirements.
- May support internal and external audits.
- Measure Analyze and report key process indicators.
- Develop the quality report and communicate product/process performance to the Operation Unit assigned for new products.

**What You Will Need**
- B.S. in engineering, engineering related discipline or equivalent experience.
- 4 years minimum in Quality Assurance or related functional area such as Design
- Transfer/Manufacturing Transfer; preferably in medical device, or other regulated industry.
- Knowledge of inspection methods in the design and production of electro-mechanical and/or mechanical equipment.
- Excellent written/oral communication skills.
- Demonstrated mechanical/electrical troubleshooting and problem-solving skills.
- Strong knowledge in Validation per FDA-QSR and ISO guidelines.
- Statistical Knowledge and statistical results interpretation.
- Fully Bilingual (English and Spanish).
- ISO13485 and ISO14971 knowledge.
- Development and implementation of design and process controls.
- Experience with SPC.
- Familiarity with FDA Guidance on

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