Job Description
Boston Scientific is a leading global medical device company dedicated to transforming lives through innovative medical solutions. We are currently seeking a talented and driven Supplier Quality Engineer to join our dynamic team in Penang.
In this critical role, you will be responsible for driving improvement and implementing corrective actions in the quality of components sourced from external suppliers. Your expertise will directly impact our ability to deliver life-changing medical devices to patients worldwide.
You will collaborate closely with cross-functional teams including procurement, manufacturing, and design engineering to ensure supplier performance meets our stringent quality standards. Your analytical mindset and problem-solving abilities will be key in identifying root causes of quality issues and implementing sustainable solutions.
This position offers an excellent opportunity for a mid-to-senior level professional looking to advance their career in the medical device industry while making a meaningful difference in patient care. Boston Scientific provides a supportive work environment with opportunities for professional growth and development.
We offer competitive compensation packages, comprehensive benefits, and the chance to work with cutting-edge technology alongside industry experts. If you are passionate about quality and want to contribute to saving and improving lives, we encourage you to apply.
Responsibilities
- Drive continuous improvement initiatives and corrective action plans for supplier-related quality issues
- Conduct regular supplier audits and assessments to ensure compliance with quality standards and regulations
- Analyze supplier performance metrics and implement improvement strategies to meet quality KPIs
- Collaborate with procurement and engineering teams to evaluate and approve new suppliers
- Investigate root causes of component quality issues and develop effective corrective and preventive actions (CAPA)
- Ensure supplier documentation and quality records are maintained in accordance with regulatory requirements
- Participate in design transfer activities and process qualification for sourced components
- Provide technical guidance and support to suppliers on quality-related matters
Qualifications
- Bachelor's degree in Engineering, Quality Management, or related technical field
- Minimum 3-5 years of experience in supplier quality, quality engineering, or manufacturing quality role
- Strong understanding of quality management systems (ISO 13485, ISO 9001) and regulatory requirements
- Experience with supplier auditing and quality assurance methodologies (Six Sigma, Lean Manufacturing)
- Proficiency in quality tools such as FMEA, root cause analysis, and statistical process control
- Excellent problem-solving and analytical skills with attention to detail
- Effective communication and interpersonal skills to work with cross-functional teams and suppliers
- Knowledge of medical device regulations (FDA, CE Mark) is preferred