Supplier Qual Engineer II - Exempt

This position is urgent, and the hiring manager will take action on candidates right away. Located in the dynamic area of North Haven, CT, this role offers an exciting opportunity to work at the forefront of Robotic Surgical Technologies.

Responsibilities

The Supplier Quality Engineer is responsible for managing finished goods Contract Manufactured (CM) for Robotics Surgical Technologies. Primary duties include:

• Managing all QMS related matters pertaining to supplier selection, processing supplier change requests, part/process qualification, manufacturing, QMS development, and technical quality/service/costs improvements.
• Working with new and existing Clients/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including MSAs, PPAP, SCR, Quality Plans, Control Plans, and FMEAs.
• Ensuring that suppliers deliver quality parts, materials, and services.
• Qualifying suppliers according to company standards and administering a Certified Supplier Program in receiving inspection to ensure cost-effectiveness.
• Monitoring parts from acquisition through the manufacturing cycle and communicating and resolving supplier-related problems as they occur.
• Developing and prioritizing an auditing schedule to ensure that designated suppliers are audited regularly to ensure good manufacturing practices (GMP) and quality standards are met.
• Evaluating suppliers' internal functions to assess their overall performance and providing feedback in assessment of their operation.

Top 3 Technical Skills Required

• Lead, support, review, and approve supplier change requests (SCR), Validation, TMV, PPAP, SCAPA, QMS, etc.
• Work with new and existing Clients/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including Quality Plans, Control Plans, and FMEAs.
• Familiarity with Medical industry requirements such as ISO 13485, 21 CFR 820 standards, etc.

Education and Experience

• Bachelor’s Degree in Engineering/Scientific/Electronic or technical field.
• Minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience.

Work Schedule

The contractor will be working 40 hours weekly and is required to be onsite at the North Haven, CT location.

Additional Information

Interviews are being scheduled now. Please note that the hiring manager will be on vacation from May 27 to June 8, but a team member will be reviewing resumes and scheduling interviews during this time.