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Senior Quality System Engineer at Boston Scientific Corporation Malaysia
Maple Grove, Minnesota, United States -
Full Time

Start Date

Immediate

Expiry Date

16 Apr, 26

Salary

0.0

Posted On

16 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Quality Systems, Internal Audits, Problem-Solving, Regulations, ISO 13485, Analytical Skills, Risk-Based Decisions, Audit Support, Communication Skills, Project Management, Organizational Skills, Collaboration, Detail-Oriented, Medical Device Industry, Pharmaceutical Industry, Quality Principles

Industry

Medical Equipment Manufacturing

Description
Your responsibilities will include: 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.' Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues. 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. 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
Execute internal audits for the Maple Grove and Arbor Lakes sites and support participation in the Medical Device Discovery Appraisal Program. Apply systematic problem-solving methodologies to resolve quality issues.