Senior Quality System Engineer

Key Responsibilities

• 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.

Requirements

• 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.

Required Skills

• 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.