Equipment Technician II – 1st Shift

The Opportunity

This position works out of our Westfield, IN location in the Structural Heart division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

As the Supplier Quality Engineer II, you’ll be responsible for conducting supplier audits, qualifying new suppliers, and monitoring the performance of current suppliers. Must be able to handle supplier audit situations and interactions in a tactful, professional and effective manner.

What You’ll Work On

• Supplier Audits Develop and execute to a supplier audit schedule per current requirements.

• Develop audit plans and associated supplier communications.
• Approve and monitor Supplier CAPA plans and activities to closure including objective evidence of effectiveness.
• ISO lead auditor certification or equivalent is preferred.
• Qualify and then monitor supplier performance Per current requirements perform activities that will qualify new suppliers and monitor current supplier base to ensure the status of the suppliers is correct.
• Work with suppliers as needed to ensure their performance is acceptable per site requirements.
• Work with Design and Development, Manufacturing, Purchasing and IQA when qualifying and monitoring supplier performance.
• CAPA Through the supplier audits and internal issues with supplier product, issue SCARs for supplier corrective/preventive action activities.
• Analyze Supplier information and present supplier metrics to appropriate CAPA boards.
• Demonstrated writing and communication skills are required for this position.
• A thorough understanding of the ISO/QSRs and the ability to apply that knowledge with an understanding of business operations to achieve regulatory compliance is needed.
• Must be able to explain audit results and influence other's understandings of audit observations in a tactful and professional manner.

Pay and Shift

The salary range for this position is $57,300 - $114,700

Required Qualifications

Bachelors Degree in Engineering or other related area

2 - 5 years experience in technical or other QA related position

Preferred Qualifications

2- 5 years experience in medical device or similar regualted industry