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Sr Quality Systems Engineer - CAPA at Boston Scientific Corporation Malaysia

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Mar, 26

Salary

0.0

Posted On

02 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

CAPA, Root Cause Analysis, Problem-Solving Methodologies, Corrective Action Plans, Effectiveness Verifications, Project Management, Quality Systems, Regulatory Compliance, Technical Writing, Documentation, Analytical Skills, Attention to Detail, Risk-Based Decision-Making, ISO 13485, FDA QSR, Power BI, Tableau

Industry

Medical Equipment Manufacturing

Description

Act as CAPA subject matter expert at Maple Grove, providing guidance and making sound decisions on how to best apply the processes efficiently, effectively and compliantly. Mentor CAPA teams (both cross-functional and direct team members) with applying tools in root cause analysis, problem-solving methodologies, corrective action plans, effectiveness verifications and project management activities. Skilled at identifying, prioritizing, communicating and resolving systematic quality issues Providing continuous and rigorous assessment of CAPA records to ensure they are robust, compliant with BSC processes and regulations (FDA, ISO 13485 and Medical Device Requirements), and timely throughout the CAPA lifecycle. Determining and tracking actionable CAPA metrics and trends to assess program effectiveness and influence key stakeholders' engagement Support site and global CAPA initiatives and continuous improvement projects. Bachelor's degree with 5+ years, or Master's degree with 3+ years, in medical device manufacturing, quality, or regulatory/compliance. Understanding of quality system requirements as stated in 21 CFR Part 820 and ISO 13485. Strong technical writing, documentation, and analytical skills. Attention to detail and risk-based decision-making. Degree in Science or Engineering. 5+ years in Quality Systems and/or CAPA management. Training/certification in ISO 13485 and FDA QSR (21 CFR Part 820). Proficiency in Power BI and Tableau. Proactive able to work independently, as a team leader or member, and enjoy being part of a highly visible team. Project management experience A passion for continuous improvement.

Responsibilities

Act as a CAPA subject matter expert, providing guidance and making decisions on efficient and compliant processes. Mentor CAPA teams and assess CAPA records to ensure compliance with regulations and timely management throughout the CAPA lifecycle.