Posted in Other 30+ days ago.
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Type: Full Time
Location: Marlborough, Massachusetts
Purpose and Passion * Comprehensive Benefits * Life-Work Integration * Community * Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we re solving some of the most important healthcare industry challenges. Together, we re one global team committed to making a difference in people s lives around the world. This is a place where you can find a career with meaningful purpose improving lives through your life s work.
Supplier Quality Engineer II
About this role:
Supplier Quality Engineers provides focused Quality Engineering support to the procurement of services and materials to Boston Scientific s Marlborough facility. Develops, establishes and maintains Supplier Quality Engineering methodologies, systems, and practices which meet BSC, customer, and
regulatory requirements. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Success in this role requires integration with suppliers, as well as cross-functional engagement within Boston Scientific, including but not limited to: Purchasing, Research and Development, Manufacturing Engineering, Regulatory Affairs, Global Supply Chain, Project Management, Supplier Sourcing, as well as other Quality functions in Endoscopy or other Divisional groups.
Your responsibilities include:
* Plans and conducts scheduled audits of suppliers to assess compliance with Boston Scientific requirements. Includes audit scheduling, investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
* Conducts and confirms follow-up actions on Supplier Quality System Audits. Assesses supplier capabilities through direct visits, technical discussions and Quality System Audits.
* Prepares detailed trip reports and Audit Reports to document audit findings and observations.
* Communicates quality issues to suppliers as needed and provides assistance to develop corrective actions.
* Reviews, understands, and implements updates related to BSC Policy changes. Includes incorporation of this information into corporate and divisional programs through document reviews, protocol reviews, validation reviews, and training programs.
* Participates with Corporate and regional Supplier Quality organization on policy/procedure/guideline development. Includes generation, review, and implementation of these documents.
* Generates Supplier Performance Reports.
* Tracks and trends supplier performance, taking remedial action as needed.
* Maintains accuracy of Vendor Audit Report and Supplier Profile Reports.
* Provides guidance to Purchasing and Engineers in applying Supplier Quality system requirements.
* Contributes to and participates in supplier performance reviews.
* Ability to travel 10-30% both domestically and internationally
What we re looking for in you:
* 2-5 years experience in Manufacturing or Quality with a Bachelor s degree Engineering or related technical discipline.
* 0-1 year experience with a Master s degree in Engineering or equivalent medical device industry experience.
* Excellent written and verbal communication skills
* Experience in the medical device industry.
* Knowledge FDA, ISO13485, and the medical device industry quality requirements associated with manufacturing and supplier controls
* Demonstrated ability to identify and work with cross functional organizations to solve problems
* Strong command of MS Office Word, Excel, Powerpoint, Visio
* Ability to rapidly learn and use new applications
* Previous experience Supplier Quality, Quality Engineering, or Manufacturing background.
* Lead auditor certification ISO 13485 and previous auditing experience.
* Experience in problem solving and process improvement methodologies
* Process Validation, NCEP, CAPA expereince
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you re looking to truly make a difference to people both around the world and around the corner, there s no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Requisition ID: 421976
Nearest Major Market: Boston
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