Senior Quality Systems Auditor & Improvement Lead

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

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.