Senior Supplier Quality Engineer- SFMD Endoscopy

Boston Scientific-posted 3 months ago
$86,600 - $164,500/Yr
Senior
Hybrid • Marlborough, MA
5,001-10,000 employees
Merchant Wholesalers, Durable Goods
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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. In this role, you will support SFMD products within the Endoscopy division with a primary focus on capital equipment. The Sr. Supplier Quality Engineer plays a critical role in maintaining compliance with ISO 13485, FDA QSR (21 CFR 820) and other applicable medical device regulations.

  • 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 supplier audits to assess compliance with regulatory standards and Boston Scientific requirements.
  • Manages sustaining quality issues, process change impacts, and design change implementations in the BSC Quality System.
  • Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centers.
  • Investigates complaints and manages NCEPs at OEM suppliers where the issue is manufacturing related.
  • Lead investigations into supplier-related nonconformances and implement effective Corrective and preventive actions (CAPA).
  • Provide manufacturing support at external vendors by addressing manufacturing process defects and implementing process improvements utilizing Quality System tools.
  • Lead the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers.
  • Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations.
  • Supports and performs Finished Good Documentation changes in support of ongoing design changes or labeling updates.
  • Supports projects and contributes to consistently hitting project milestones.
  • Collaborates on developing crisp and clear project plans and strong contingency plans as part of project planning process.
  • Review and approve Supplier documentation including validation protocols (IQ/OQ/PQ), FMEAs, control plans and inspection methods.
  • Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development.
  • Identifies and advises management on potential improvements to quality systems and processes in the company.
  • Champions 100% compliance to company policies and SOP's.
  • BS degree in engineering or technical field with minimum of 5 years of relevant experience in supplier engineering, supplier management, or supplier quality engineering.
  • Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.
  • Experience with capital equipment or electronics including product development, servicing, and repair.
  • Project management: ability to influence cross functional global teams spanning Quality, Operations, R&D, and Sourcing.
  • Experience in process validation, design controls, risk management, CAPA, SCAR.
  • 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%.
  • 7+ years of medical device engineering experience preferred.
  • Leadership 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.
  • Compensation will be commensurate with demonstrable level of experience and training.
  • Variable compensation may include annual bonus target and long-term incentives.
  • Core and optional employee benefits offered by Boston Scientific.
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