Quality System Engineer III

Boston Scientific Gruppe; Maple Grove, Northern (MN, KY); Hybrid; USD 78,000 - 149,000; Full time

Job summary

Boston Scientific Corporation in Maple Grove, MN is seeking a Quality System Engineer III to serve as a quality representative supporting quality initiatives at department, site, and regional levels. The role focuses on Internal Audit programs to ensure the Quality Management System complies with regulations and BSC procedures.

The position is hybrid, requiring in-office presence at least 3 days per week in Maple Grove, MN.

Qualifications

• Minimum of 3 years of relevant quality engineering experience in the medical device or pharmaceutical industry
• Minimum of 1 year experience in a role that includes auditing
• Understanding of regulations/standards applicable to BSC Quality Management (such as 21 CFR 820 and ISO 13485)
• Strong verbal and written communication, including technical writing, and organizational skills
• Detail oriented with the ability to analyze information quickly
• Able to use a risk-based approach for making quality and business decisions

Responsibilities

• Execute Internal Audits of the Maple Grove Site as assigned (Audits may include Production, Design, Regulatory, Management Controls, and CAPA)
• Lead Internal Audits, develop an Audit Plan, and facilitate Audit Meetings
• Support and lead Internal Audit initiatives, continuous improvement opportunities, and projects
• Serve as a Quality System Expert resource, supporting External Audit readiness and cross-functional guidance

Skills

Quality engineering

Auditing

Regulatory knowledge

Technical writing

Risk-based decisions

Job description

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The Quality System Engineer III will serve as a Quality representative to provide support of quality initiatives and goals at a departmental, site, and regional level. This role will support Audit Excellence at Maple Grove, specifically focusing on the Internal Audit program to ensure the compliance and effectiveness of the BSC Quality Management System against external regulations/standards and BSC procedures.

At Boston Scientific, we value collaboration and synergy. This is a hybrid work mode position located in Maple Grove, MN with the expectation to be in the office at least 3 days per week.

Your responsibilities include:

• Execute Internal Audits of the Maple Grove Site as assigned
  • Audits may include: Production, Design, Regulatory, Management Controls, and CAPA
  • Evaluate and document the compliance of assigned areas via: Tours, Interviews, Documentation and Record Review
  • Formulate and document nonconformities and opportunities for improvement
  • Understand procedures and evaluate compliance to applicable requirements
• Lead Internal Audits
  • Collaborate cross-functionally with Audit Area Management for audit scheduling, execution, and initiation of audit nonconformities
  • Develop an Audit Plan, including scope, objectives, criteria, and planned schedule
  • Facilitate Audit Opening and Closing Meetings
  • Provide work directions to Audit Team
  • Complete Audit records, including Audit Report and Audit Trails
  • Communicate audit progress and results to Auditees and Leadership
• Support and lead Internal Audit initiatives, continuous improvement opportunities, and/or projects
  • Coordinate activities, communicate progress, collaborate on key deliverables, and influence action.
  • Make pragmatic, risk-based decisions and provide input regarding how to apply requirements and best practices for processes compliance, efficiency, and effectivity.
• Serve as a Quality System Expert resource as requested
  • Support External Audit readiness and execution, including performing production line walks and documentation review.
  • Partner cross-functionally to provide guidance on BSC’s Quality Management system and external regulations/standards.

Required Qualifications:

• Minimum of 3 years of relevant quality engineering experience in the medical device or pharmaceutical industry
• Minimum of 1 year experience in a role that includes auditing
• Understanding of regulations/standards applicable to BSC Quality Management (such as 21 CFR 820 and ISO 13485)
• Conceptual, practical, and functional knowledge of quality principles, with a general understanding of related job functions
• Strong verbal and written communication, including technical writing, and organizational skills
• Detail oriented with the ability to analyze information quickly
• Able to use a risk-based approach for making quality and business decisions

Preferred Qualifications:

• 3+ years of experience in audit execution (such as Internal Audits, Supplier Audits, or Regulatory Audits)
• ASQ Certified Quality Auditor
• Proactive, able to work independently with minimal supervision, as a team leader or member
• Ability to collaborate and communicate with all levels of the organization
• Continuous improvement mindset with a passion for Quality
• Proven ability to influence without authority in a matrixed organization
• Strong networking skills to foster collaborative relationships

Requisition ID:633424

Minimum Salary:$78300

Maximum Salary: $148800

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: Systems Engineer, Internal Audit, Pharmaceutical, Medical Device Engineer, Quality Engineer, Engineering, Finance, Science