Senior Supplier Quality Engineer- SFMD Endoscopy

Recruiter: Spencer Gregory Hale

Senior Supplier Quality Engineer- SFMD Endoscopy

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. 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.

Your responsibilities 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 supplier audits to assess compliance with regulatory standards and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
• 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.

New Product Development:

• 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.

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 technical fieldwith 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%. 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:

• 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.

Requisition ID:613588

Minimum Salary:$86600

Maximum Salary: $164500

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Among other requirements, Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.