- Implementation of internal requirements and external laws, regulations, guidances and standards as applicable to Boston Scientific quality systems.
- Has expertise in internal auditing techniques and is familiar with all regulatory requirements (e.g., FDA, ISO, cGMP and MDR).
- Lead and support site External Inspections.
- Plan, coordinate and conduct scheduled audits to assess compliance with FDA, ISO, cGMP and MDR, other applicable standard requirements and internal requirements. To include audit scheduling, investigation, and evaluation of audit observation and findings.
- Identify areas of potential noncompliance or improvements by managing and conducting internal audits to schedule.
- Attend global conference calls and meetings related to the internal audit process and etc.
- Lead the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
- Support the site corrective and preventive actions process.
- Maintain the BSC Penang CAPA process.
- Develop and distribute CAPA metrics for facility management and the CAPA board. Work with CAPA phase owners to ensure timely completion of CAPAs.
- Educate functional areas on quality system requirements.
- Participate cross functionally and across business units to standardize Boston Scientific Quality System policies and procedures.
- Potentially act as team member in supporting quality disciplines, decisions, and practices.
- May on occasion be required to travel in order provide support the business or other sites in this area of responsibility.
- Gather facility quality metrics for the management review presentation.
- Collect and analyze business/quality system process data from different parts of the company.
- If applicable, to provide quality assurance support and direction to the analytical laboratory responsible for the testing and analytical batch release of all drug combination products and raw materials used at Penang Site. Responsible for ensuring that Raw Materials (specific to Active Pharmaceutical Ingredients, API), Finished Goods, non-routine and Stability testing is carried out in accordance with cGMP both in BSC laboratories and at the contract laboratories. Provide support and guidance in the areas of cGMP, Compliance, Regulatory and laboratory investigation including Out Of Specification/Lab Investigation Report/Out Of Trend. Preparation and compilation of Annual Product Reviews on DES products. Schedule and complete laboratory assessments.
- Degree qualified in Science, Engineering, or a related discipline.
- Minimum 9 years of experience in quality background.
- Experience in the medical device industry is desirable.
- Experience in Non-Conforming Events and CAPA management.
- Experience in Internal Audit and External Audit activities.
- Experience in Management Review processes.
- Strong understanding of quality systems, regulatory compliance, and continuous improvement methodologies.
- Ability to work cross-functionally and drive quality system initiatives across the organization.
- Knowledge of ISO 13485.
- Knowledge of EU MDR.
- Knowledge of FDA Regulations.
- Knowledge in cGMP and Combination Device Regulations.
- Lead Auditor qualification is desirable.
- Internal and external audit management.
- CAPA systems and quality system management.
- Regulatory compliance and quality assurance expertise.
- Quality metrics analysis and management review reporting.
- Strong analytical, problem-solving, and communication skills.
- Cross-functional stakeholder management and collaboration.
About Us
As a global medical technology leader for more than 45 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
Skills Required
- Degree in Science, Engineering, or related discipline
- Minimum 9 years of experience in quality background
- Experience in the medical device industry
- Experience in Non-Conforming Events and CAPA management
- Experience in Internal Audit and External Audit activities
- Experience in Management Review processes
- Strong understanding of quality systems, regulatory compliance, and continuous improvement methodologies
- Ability to work cross-functionally and drive quality system initiatives
- Knowledge of ISO 13485
- Knowledge of EU MDR
- Knowledge of FDA Regulations
- Knowledge in cGMP and Combination Device Regulations
- Lead Auditor qualification
- Internal and external audit management
- CAPA systems and quality system management
- Quality metrics analysis and management review reporting
- Strong analytical, problem-solving, and communication skills
- Cross-functional stakeholder management and collaboration
Boston Scientific Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Boston Scientific and has not been reviewed or approved by Boston Scientific.
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Healthcare Strength — Healthcare coverage is positioned as comprehensive, spanning medical, dental, vision, life, and disability insurance alongside mental health resources. Family planning support and broader care navigation offerings further strengthen the health-related value of the package.
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Retirement Support — Retirement benefits stand out through a 401(k) match described as best-in-class and supported by profit sharing and an employee stock purchase plan. High participation in retirement programs is also highlighted as part of the overall financial benefits footprint.
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Leave & Time Off Breadth — Time off is described as generous, with reports of 20+ vacation days and up to four weeks in some roles, plus paid holidays and sick leave. Longer-term options such as extended unpaid family leave and a personal enrichment sabbatical expand flexibility beyond standard PTO.
Boston Scientific Insights
What We Do
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. For more information, visit www.bostonscientific.com and connect with us on X, Instagram, and Facebook. At Boston Scientific, you will find purpose, a place to grow and opportunities to cultivate your passions. To search and apply for open positions, visit https://bostonscientific.eightfold.ai/careers. You may also review our social media guidelines at http://www.bostonscientific.com/social.
