Supplier Quality Engineer - Compunnel : Job Details

JOB SUMMARY The Supplier Quality Engineer is responsible for ensuring exceptional product quality, regulatory compliance, and optimized cost of quality. This role develops, establishes, and maintains quality engineering methodologies, systems, and practices that meet Boston Scientific (BSC), customer, and regulatory requirements. Acting as a Quality representative, the engineer improves awareness, visibility, and communication on quality initiatives to support departmental, site, divisional, and corporate quality goals. This position provides focused quality engineering support within areas such as new product development, operational support, supplier assurance, and compliance systems. Key Responsibilities

• Develop and implement effective process control systems to support product development, qualification, and manufacturing.
• Lead implementation of assurance activities, process controls, and CAPA systems to meet internal and external requirements.
• Act as a leader or team member in supporting quality disciplines, decisions, and practices.
• Apply systematic problem-solving methodologies to identify, prioritize, and resolve quality issues.
• Ensure streamlined business systems that effectively address and resolve quality issues.
• Improve supplier quality performance through Part Quality Plan (PQP) implementation, review, and approval.
• Approve supplier selection through robust qualification processes, including supplier audits.
• Ensure supplier compliance with Quality Management System (QMS) and regulatory standards.
• Drive development and execution of effective CAPA plans at assigned suppliers.

Required Qualifications

• Bachelor’s Degree in an engineering or technical discipline (or non-technical degree with at least 7 years of relevant experience).
• Minimum 5 years’ experience in manufacturing, engineering design, quality assurance, or regulatory assurance.
• Strong problem-solving and root cause analysis skills, with the ability to influence and drive change.

Preferred Qualifications

• ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA).
• Knowledge of Quality Management System tools and continuous improvement methodologies.
• Supplier quality experience within the medical device industry.

Certifications ASQ CQE or CQA certification preferred. Education Bachelor’s degree in engineering, Technical Discipline, or equivalent required. Certification: Certified Quality Auditor