Senior Supplier Quality Engineer - Medical Devices Leader

Boston Scientific; Indiana; On-site; USD 81,000 - 153,900; Full time

Job summary

Boston Scientific is seeking a Senior Supplier Quality Engineer to lead quality improvements for direct components from external suppliers. You will drive corrective actions, support supplier selection, and develop acceptance criteria for materials.

You will mentor teams, partner with Design Quality Assurance, R&D, Regulatory, and Sourcing, and ensure compliance with QSR and ISO requirements, CAPA, and process controls while improving supplier performance.

Qualifications

• BS in Engineering, Chemistry or related technical field.
• 5+ years of quality engineering experience in medical device manufacturing.
• Manufacturing Process Controls experience.
• Understanding of QSR and ISO requirements for Material/Purchasing Controls, Product Realization, Validation and CAPA.

Responsibilities

• Assess potential new suppliers for technical, quality and manufacturing capabilities.
• Generates and maintains incoming inspection procedures and trains inspectors.
• Analyzes incoming material defects and drives corrective action with suppliers.
• Investigates field failures related to supplier materials and develops corrective actions.
• Influences cross-functional global teams (DQA, R&D, Regulatory, Sourcing).
• Mentors others in core Supplier Quality Engineering skills and quality tools.

Skills

Quality engineering

QSR compliance

ISO standards

Education

Bachelor of Science in Engineering, Chemistry or similar technical field

Job description

Boston Scientific is seeking a Senior Supplier Quality Engineer to lead quality improvements for direct components from external suppliers. You will drive corrective actions, support supplier selection, and develop acceptance criteria for materials.

You will mentor teams, partner with Design Quality Assurance, R&D, Regulatory, and Sourcing, and ensure compliance with QSR and ISO requirements, CAPA, and process controls while improving supplier performance.