Senior Quality System Engineer

bostonscientific•Maple Grove, MN

12d•$85,000 - $161,500•Hybrid

About The Position

As a Senior Quality System Engineer supporting external audits, the incumbent will be a key Quality representative responsible for driving Audit Excellence at the Maple Grove and Arbor Lakes sites. The incumbent will lead and coordinate efforts around audit readiness, preparation, execution, and closure activities. This includes interfacing with regulatory authorities (e.g., FDA, Notified Bodies, and global agencies), site quality teams, and global stakeholders. This role will also contribute to internal audit execution and support Boston Scientific’s participation in the FDA’s 'Case for Quality' program.

Requirements

Minimum of Bachelor’s degree and 5 years' experience in the medical device or pharmaceutical industry.
Minimum of 2 years' experience in a Quality Systems role that includes internal or external audit support.
In-depth knowledge of regulations/standards such as 21 CFR 820 and ISO 13485.
Strong understanding of quality principles and interrelated job functions.
Highly detail-oriented with strong analytical skills.
Ability to make sound, risk-based decisions.

Nice To Haves

Proven experience managing, coordinating, or supporting external audits of medical device quality systems.
Minimum of 5 years' experience in audit support (internal, supplier, notified body, or regulatory audits).
Excellent verbal and written communication, interpersonal, project management, and organizational skills.
Ability to understand procedural documents and evaluate documents for compliance with applicable regulations and requirements.
Ability to collaborate and communicate effectively across all levels of the organization.
Ability to be proactive, work independently, and contribute to a highly visible team.

Responsibilities

Lead Maple Grove external audit preparation, execution, and closure activities, including managing nonconformance and action response processes as needed.
Lead and support audit readiness strategies for both Maple Grove and Arbor Lakes sites.
Serve as the primary site representative on the External Audit Global Community of Practice.
Collaborate with other Boston Scientific sites to provide cross-site external audit support as needed.
Execute internal audits periodically for the Maple Grove and Arbor Lakes sites.
Support continued participation in the Medical Device Discovery Appraisal Program as part of FDA’s ‘Case for Quality.’
Promote a work environment that supports the Global Quality Policy, continuous improvement, and Boston Scientific’s Core Values.
Serve as an effective leader or team member in support of quality disciplines, decisions, and practices.
Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
Partner with internal teams to provide guidance on Boston Scientific’s Quality Management System and applicable regulations/standards.