Supplier Quality Engineer II - Endoscopy SFMD

Boston Scientific; Marlborough (MA); On-site; USD 75,000 - 143,000; Full time

Job summary

Boston Scientific is seeking a Supplier Quality Engineer II for the Endoscopy SFMD team in Massachusetts. You will collaborate with suppliers and cross-functional internal teams to ensure finished devices meet regulatory and customer quality expectations, with patient safety as a priority.

Responsibilities include sustaining engineering, supplier audits, CAPA and change control, new product development support, and quality system improvements across global teams.

Qualifications

• BS degree in engineering or technical field required.
• 2+ years of quality engineering in medical devices or 3+ years in a regulated industry.
• Experience in medical device, automotive, aeronautical, or other regulated industry.

Responsibilities

• Sustaining Engineering: identify quality issues, review CAPAs, track supplier performance.
• New Product Development: support quality deliverables and onboard suppliers/devices.
• Quality System Champion: develop policies and drive compliance with SOPs.

Skills

Communication skills

Independent

ERP/PLM learning

Travel readiness

Education

BS degree in engineering/technical field

ASQ certification desired

Tools

ERP

PLM

Job description

Supplier Quality Engineer II - Endoscopy SFMD

About the role:

The Sourced Finished Medical Device (SFMD) Supplier Quality Engineering organization at Boston Scientific is a global team that oversees a diverse network of suppliers which manufacture finished devices for distribution. This individual will demonstrate a primary commitment to patient safety and will be responsible for collaborating with suppliers and cross-functional internal teams to ensure product quality meets our customer's expectations.

Key responsibilities include:

Sustaining Engineering:

• Proactively identifies and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Review and approve supplier corrective action plans and verification of effectiveness documentation.
• 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.
• Tracks and trends supplier performance and provides key quality trending information and data for Management Review and Complaint Reviews.

New Product Development:

• Support the execution of SFMD Quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers and innovative medical devices.
• Generate/review quality plans, agreements, product specifications, component qualifications, 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.

Qualifications:

Required qualifications:

• BS degree in engineering or technical field.
• 2+ years of quality engineering experience within med device (or 3+ years of quality engineering experience within a different regulated industry).
• Experience in medical device, automotive, aeronautical, or other regulated industry.
• Ability to communicate effectively, and concisely package information to deliver key points; appropriately scale communication style and depth according to the audience.
• Ability to work independently; organized and self-driven.
• Ability to rapidly learn and use new software applications (e.g., ERP, PLM).
• Domestic and international travel up to 25%.

Preferred qualifications:

• Ability to influence cross functional global teams spanning Supplier Management, Quality, Operations, R&D, Design Assurance, and Sourcing. .
• Experience in process validation, design controls, risk management, and CAPA.
• Lead auditor of quality systems experience (ISO 13485 or similar).
• ASQ certification (CQE, SSGB, SSBB) desired.

Minimum Salary:$75100

Maximum Salary: $142600

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 identity, 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.