Supplier Quality Engineer II Job

  • Anywhere

Company :
Boston Scientific

Location :
Marlborough, Massachusetts

Expiry Date :
Sun, 06 Dec 2020 23:59:59 GMT

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Description :
Date: Nov 4, 2020 Location: Marlborough, MA, US, 01752 Company: Boston Scientific 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 the role: The Sourced Finished Medical Device (SFMD) organization at Boston Scientific is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Senior Supplier Quality Engineer will demonstrate a primary commitment to patient safety and collaborate with cross-functional internal/external resources to continually improve our supplier’s manufacturing processes. Your responsibilities will include: Sustaining Engineering: * Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation. * Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers. * Plans and leads audits of suppliers to assess compliance with regulatory and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions. New Product Development: * Supports the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers. * Generates and reviews quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations. Quality System Champion: * Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents. * Identifies and advises management on potential improvements to quality systems and processes in the company. * Champions 100% compliance to company policies and SOP’s. What we’re looking for in you: Minimal Qualifications: * BS degree in engineering or related technical field with minimum of 2-4 years of relevant experience. * Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry. * Project management: ability to influence cross functional global teams spanning quality, operations, R & D, and sourcing. * Experience in process validation, design controls, risk management, and CAPA. * Ability to work independently; organized and self-driven. * Articulate communicator; adept at packaging and appropriately scaling information to the intended audience. * Ability to rapidly learn and use new software applications (e.g., PLM, ERP). * Domestic and international travel up to 25%. Note: COVID-19 precautions currently restrict travel. At Boston Scientific, our priority is to protect and aid the health and safety of our employees, our physician customers, and their patients. Preferred Qualifications: * Medical device engineering experience preferred. * Experience on a materials or service commodity team. * Lead auditor of quality systems experience (ISO 13485 or similar). * ASQ certification (CQE, CBA, SSGB, SSBB) strongly desired. About us 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 Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination. Requisition ID: Nearest Major Market: Boston Job Segment: Quality Engineer, Semiconductor, Medical, Engineer, Engineering, Science, Quality, Healthcare