Supplier Quality Engineer II

Redbock - an NES Fircroft company; North Haven (CT); On-site; USD 85,000 - 105,000; Full time

Job summary

Redbock - an NES Fircroft company in North Haven, CT, seeks a Supplier Quality Engineer II for a 12-month contract. You will lead supplier quality activities, manage SCRs, PPAPs, QMS development, and work with contract manufacturers to ensure GMP/ISO 13485 compliance.

The role emphasizes collaboration with suppliers to implement Quality Plans, Control Plans, and FMEAs, ensuring quality parts and cost-effective improvements across the supply chain in the robotics medical domain.

Qualifications

• Bachelor's degree required
• Minimum 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Responsibilities

• Ensures that suppliers deliver quality parts, materials, and services.
• Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
• Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure GMP and quality standards are met.
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.

Skills

Lead, support, review and approve SCR/

QA systems development

Medical ISO/FDA knowledge

Education

Bachelor’s Degree in Engineering/Scientific/Electronic or technical field

Job description

Supplier Quality Engineer II (12 month contract // North Haven, CT):

***W2 ONLY, C2C candidates, or Candidates with the following Visa Status will not be accepted: H1B, OPT, OPT-STEM***

Top 3 Skills:

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

Education Required: Bachelor’s Degree in Engineering/Scientific/Electronic or technical field

Years’ Experience Required: Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Description:

The Supplier Quality Engineer is responsible for managing finished goods Contract Manufactured (CM) for Robotics Surgical Technologies. Primary duties are focused on all QMS related matters pertaining to supplier selection, processing supplier change request, part/process qualification, manufacturing, QMS development, and technical quality/service/costs improvements. Work with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including MSAs, PPAP, SCR, Quality Plans, Control Plans, and FMEAs.

Duties:

• Ensures that suppliers deliver quality parts, materials, and services.
• Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
• Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.