Sr. Supplier Quality Engineer - Electronics

Boston Scientific; United States; On-site; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific is seeking a Sr. Supplier Quality Engineer - Electronics to lead supplier quality initiatives and drive improvements across the electronics supply base.

The role focuses on audits, CAPA, and collaboration with Design QA, R&D, Regulatory, and Sourcing to ensure compliance with ISO 13485, FDA 21 CFR 820, and ISO 9001. The position requires a BS in Engineering with at least 5 years of experience in supplier quality, strong problem-solving skills, and up to 10% travel.

Qualifications

• BS degree in Engineering with minimum of 5 years of relevant quality engineering experience.
• Experience in various component manufacturing or raw material production.
• Communicates effectively and concisely to deliver key points.
• Ability to influence cross functional global teams spanning Design Quality Assurance, R&D, Regulatory, Supplier Engineering, and Sourcing.
• Builds strategic and trusting relationships through technical capability, critical thinking, and teamwork.
• Experience in Quality Management Systems (ISO 13485, FDA 21 CFR 820, ISO 9001) and risk management.
• Experience with problem solving quality tools, CAPA, Technical Documentation.
• Willingness to travel domestically and internationally up to 10%.

Responsibilities

• Plans and leads audits of suppliers to assess compliance with regulatory and Boston Scientific requirements, including scheduling, investigations, and follow-up actions.
• Proactively assesses supplier capabilities through on-site visits and technical discussions and supports supplier changes.
• Develops solutions to complex problems and communicates quality issues to suppliers, applying corrective action plans.
• Leads cross-divisional and cross-functional projects delivering improvements to quality systems and processes.
• Mentors junior engineers and interacts with suppliers to drive improvements and ensure product quality.

Skills

Quality engineering

Cross-functional collaboration

Regulatory compliance

Root cause analysis

Education

Bachelor's degree in Engineering

Job description

Recruiter: Spencer Gregory Hale

Sr. Supplier Quality Engineer - Electronics

About this role:

The Arden Hills Supplier Quality Engineering team is looking for high-energy, driven, passionate people, looking to not just change jobs, but start an amazing career!

The Supplier Quality Engineer will play a key part in leading performance improvement of suppliers and increasing supplier's capabilities to consistently meet Boston Scientific's requirements. This role collaborates with cross-functional teams to address and resolve all component-related challenges throughout the supply chain including receiving inspection, manufacturing, testing, and assembly into finished goods. Additionally, the Supplier Quality Engineer will support global sourcing, manufacturing operations, and global quality systems by participating in global communities of practice and value improvement projects.

Drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures.

Your responsibilities will include:

• Plans and leads audits of suppliers to assess compliance with regulatory and Boston Scientific requirements, including audit scheduling, investigation, and evaluation of audit observations and findings, reporting, follow-up, and confirmation of follow-up actions. Proactively assesses supplier capabilities through direct on-site visits and technical discussions and supports the evaluation of proposed changes at suppliers.
• Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Communicates quality issues to suppliers, applies systematic problem-solving methodologies, and reviews and approves supplier corrective action plans and effectiveness documentation. Has a broad knowledge of a variety of alternatives and their impact on the business unit. Investigate field failures related to supplier materials. Develop corrective action plan where necessary
• Assess & drive reactive as well as proactive supplier project(s)/investigations partnering with Supplier Engineering, Manufacturing/Test operations, Commercial Sourcing, Design Assurance, R&D.
• Actively engaging in Global Sourcing category teams as a technical lead, establishing and executing Global Sourcing category objectives
• Leads cross-divisional and cross-functional projects that deliver improvements to quality systems and processes.
• Works under minimal direction regarding the direction and progress of projects and special assignments. Independently determines and develops approach to solutions. Interprets, executes and recommends modifications to company policies. Assists in establishing departmental policies and procedures. Provides leadership and mentorship to junior engineers. Work is reviewed upon completion for adequacy in meeting strategic objectives and alignment with company goals.
• Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. Interacts with suppliers. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represent a specialized field in larger project teams. Influences middle management on business solutions.
• In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented quality processes and procedures. Ensure that appropriate resources, including personnel and tools, are available to support Quality System compliance and adherence to the Quality Policy. Foster a work environment that upholds the Quality Policy and Quality System.

What we're looking for in you:

Minimum requirements:

• BS degree in Engineering or similar with minimum of 5 years of relevant quality engineering experience.
• Experience in various component manufacturing or raw material production.
• Communicates effectively and concisely pack up information to deliver key points; appropriately scales communication style and depth according to the audience.
• Ability to influence cross functional global teams spanning Design Quality Assurance, R&D, Regulatory, Supplier Engineering, and Sourcing.
• Builds strategic and trusting relationships through demonstrated technical capability, critical thinking, and teamwork behaviors.
• Experience in Quality Management Systems (ISO 13485, FDA 21 CFR 820, ISO 9001), regulatory compliance, and risk management.
• Experience with problem solving quality tools, Corrective/Preventive Actions (CAPA), Technical Documentation
• Ability to work independently and collaborate with project teams; organized and self-driven
• Domestic and international travel up to 10%

Preferred Qualifications:

• Lead auditor certification to ISO13485, 9001, TS16949 standards
• Experience with manufacturing support or process development.
• Experience with project management.

Requisition ID: 636306

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 specific prohibited substance test 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.