ClinicalQA - P5 at Boston Scientific Corporation Malaysia

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

14 Apr, 26

Salary

0.0

Posted On

14 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Regulatory Compliance, Training Development, Data Analysis, Collaboration, Critical Thinking, Medical Education, Clinical Quality Assurance, Project Management, Communication, Presentation Skills, Process Improvement, Risk Management, Learning Management Systems, Audit Preparation, Patient Safety, Quality Policy Adherence

Industry

Medical Equipment Manufacturing

Description

Serve as the quality expert for CQA and HCP training, leading teams through BSC's Quality System and acting as the SME for interpreting regulations and translating them into practical, compliant processes. Represents ICTx and WM HCP Training interests in the Global HCP Training CoP. Proactively addressing relevant topics with a keen focus on enhancing compliance, effectiveness, and efficiency of HCP training processes. Own and develop the HCP QA Assessment Schedule; oversee execution by HCP QA staff and provide strategic, tactical, and technical guidance during assessments and follow-up. Leads quality escalations discussions with global, cross-functional partners; drives and oversees NCEPs, CAPAs, and SCARs; owns corrective and preventive actions as needed. Design, implement, and sustain global quality systems; lead cross-product, cross-division best-practice sharing to boost compliance, effectiveness, and efficiency of HCP training in both commercial and clinical settings. Prepare, coordinate, and support regulatory inspections at BSC offices and clinical sites; partner with clinical leadership and CQA peers to maintain an audit-ready state for all WM and ICTx studies. Champion proactive, data-driven compliance—using metrics to identify risks, drive process improvements, and strengthen a culture of quality. Demonstrate an unwavering commitment to patient safety and product quality by adhering to the Quality Policy and all documented processes and procedures. Ensure the right resources (people, tools, and systems) are available to sustain Quality System compliance and adherence to the BSC Quality Policy. Foster a work environment that models and reinforces the Quality Policy and Quality System. Bachelor's degree in Science, Health, Engineering, or a related field. 8 plus years of experience in medical device, pharma, or a similarly regulated industry. Exceptional organization and the ability to influence without authority at all levels. Strong presentation and communication skills. Proven collaboration and critical-thinking skills. Working knowledge of U.S. and international regulations and standards applicable to BSC. Direct experience developing and implementing a Learning Management System for Physician Training Records globally Direct experience owning and driving quality assurance activities in support of NCEPs and CAPAs. Experience in Medical Education and/or Clinical Quality Assurance. Familiarity with BSC IT systems (e.g., eCAPA, Windchill, APPROVE). Experience partnering with cross-functional teams such as Regulatory, R&D, Clinical, Medical, Sales Training, and Quality. 10 plus years of experience in medical device, pharma, or a similarly regulated industry

Responsibilities

Serve as the quality expert for CQA and HCP training, leading teams through BSC's Quality System. Own and develop the HCP QA Assessment Schedule and oversee execution by HCP QA staff.