Senior Supplier Quality Engineer - SFMD

Boston Scientific Gruppe; Arden Hills (MN); On-site; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific in Minneapolis, MN is seeking a Senior Supplier Quality Engineer to oversee supplier quality for finished medical devices. You will lead audits, drive CAPA, and support new product development with cross-functional teams.

Required are a BS in engineering with 5+ years in regulated industries, strong project leadership, and experience with PLM/ERP systems. Travel up to 25% is expected.

Qualifications

• BS degree in engineering or technical field with 5 years relevantexperience.
• Experience in medical device or other regulated industries.
• Ability to influence cross-functional teams and manage projects.
• Experience in CAPA, risk management and design controls.

Responsibilities

• Evaluates and communicates quality issues to suppliers and applies problem-solving methodologies.
• Proactively assesses supplier capabilities through on-site visits and technical discussions.
• Plans and leads supplier audits and follows up on observations and corrective actions.
• Lead SFMD quality deliverables and onboard finished device suppliers in NPD.
• Collaborates on policy, procedure, and guideline development with supplier quality teams.

Skills

Quality engineering

Supplier audits

Regulatory compliance

Project management

Education

BS degree in engineering

Tools

PLM

ERP

Job description

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 include:

• 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:

• 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.

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:

• BS degree in engineering or technical field with 5 years relevantexperience.
• Experience in the medical device, automotive, aeronautical, semiconductor, or other regulated industry.
• Project management: the 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%.

Preferred qualifications:

• 7+ years of medical device engineering experience.
• 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:631234

Minimum Salary:$85000

Maximum Salary: $161500

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.

Nearest Major Market: Minneapolis
Job Segment: Senior Quality Engineer, Risk Management, Quality Engineer, Medical Device Engineer, Aeronautical Engineering, Engineering, Finance