- Review the quality of the product investigation reports and ensure compliance with standard procedures and work instructions.
- Ability to manage and coordinate strategies to maintain healthy product investigation metrics.
- Identify, analyze, investigate, monitor, document and communicate trends in Post market data.
- Communicate and educate management, operations, and other departments, as well as external customers, about product performance.
- Ensure that information gained from the complaint investigations is fed back to the Operations, R&D, design assurance, marketing and other organizations as part of the risk management and process and design input systems.
- Escalate manufacturing or design process defects from complaints, assisting in identification of primary root causes.
- High understanding of product documents and systems by reviewing product specifications, quality specifications, drawings, and working with quality, operations and quality systems; required to understand contributing factors leading to the reported complaints.
- Support audits from complaint handling/product investigation standpoint.
- Lead initiatives for product investigation improvements and complaint reduction efforts.
- Lead or provide support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
- Evaluate, support, and lead complaint product investigation and CIS -related process transfers.
- Responsible for reviewing and developing equipment validation protocols and reports, as required.
- May be responsible for supervising CIS investigators.
- Licenciature degree in Industrial, Electric, Electronic, Electromechanical Engineering or Related Field.
- English Level desired: B2:(80-89%).
- Desired knowledge: Formal Training on statistical and quality techniques desirable, ASQ Certified, Knowledge of Six Sigma, APQP or similar tools.
- At least 5 years of experience in similar position.
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Sr Quality Engineer - Turrialba, Costa Rica - Boston Scientific
Descripción
Additional Locations: N/A
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions.
About the Role:
Provide Quality Engineering support from a Post Market perspective, to manufacturing, design assurance, R&D and other functional areas, monitoring product performance in the field and capturing inputs from complaints to ensure continuous product and process improvement for the delivery of highest quality product or new products to the customer.
This position will be supporting the Complaint Investigation Site (CIS) team for the Electrophysiology division, located at the Coyol site.
Your Responsibilities Include:
What We're Looking For:
Requisition ID: 579792
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you