Supplier Quality Engineer II- Components, Acquisition

Boston Scientific Gruppe; Arden Hills (MN); On-site; USD 69,000 - 132,000; Full time

Job summary

An established industry player is seeking a Supplier Quality Engineer II to join their dynamic team in Arden Hills. This role focuses on enhancing supplier quality processes, ensuring compliance with regulatory standards, and supporting new product development initiatives. The ideal candidate will have a strong engineering background, experience in regulated industries, and excellent project management skills. Join a passionate team dedicated to patient safety and quality excellence, where your contributions will directly impact the success of innovative medical devices. This is an exciting opportunity to grow your career in a supportive and collaborative environment.

Qualifications

• 2-4 years of progressive engineering experience in a regulated industry.
• Experience with process validation, design controls, CAPA, SCAR.

Responsibilities

• Evaluate and communicate quality issues to suppliers.
• Support supplier audits and assess compliance with standards.
• Manage sustaining quality issues and process change impacts.

Skills

Engineering

Project Management

Problem Solving

Communication

Process Validation

Risk Management

Education

BS degree in engineering or technical field

Tools

PLM

ERP

Job description

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Supplier Quality Engineer II- Components, Acquisition

Onsite Location(s):

Arden Hills, MN, US, 55112

Recruiter: Spencer Gregory Hale

Supplier Quality Engineer II- Components, Acquisition

About the role:
The Global Sourcing organization at Boston Scientific is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Supplier Quality Engineer II 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 products within the Cortex acquisition in the Electrophysiology division with a primary focus on the Single-Use Device integration.

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.
• Supports 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 for suppliers within the hybridized BSC-Cortex integration Quality System, and in the BSC Quality System after products are successfully integrated.
• Investigates and solves non-conformances due to incoming inspection at the acquired site.
• Investigates complaints and manages NCEPs at the CM supplier where the issue is manufacturing-related.
• Supports and performs Supplier Change Impact Assessments for process changes at suppliers.
• Supports projects and consistently hits project milestones. Creates crisp and clear project plans and develops strong contingency plans as part of project planning process.

New Product Development:

• Support the execution of supplier quality deliverables and collaborate with cross-functional new product development teams to onboard component 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:
Minimal Qualifications:

• BS degree in engineering or technical fieldwith 2-4 years of progressive engineering 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, 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 20%.

Preferred Qualifications:

• Medical Device Industry experience
• Problem Solving and Project Management experience
• Leadership experience on a materials or service commodity team.
• Lead auditor of quality systems experience (ISO 13485 or similar).

Requisition ID:604736

Minimum Salary:$69500

Maximum Salary: $132000

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.

Nearest Major Market: Minneapolis
Job Segment: Testing, Medical Device Engineer, Manufacturing Engineer, Compliance, Medical Device, Technology, Engineering, Legal, Healthcare