Supplier Quality Engineer

Exemplar Global; North Haven (CT); On-site; USD 85,000 - 115,000; Full time

Job summary

TAJ Technologies, Inc. seeks a Supplier Quality Engineer in North Haven, CT for a 12-month project with possible extensions. Requires a bachelor’s degree and 4+ years of experience in supplier quality, with focus on QA systems, PPAP, and FMEAs in regulated environments.

Responsibilities include leading SCRs, QMS development, and collaboration with contract manufacturers to ensure quality and compliance for robotics surgical technologies.

Qualifications

• Bachelor’s degree required.
• Minimum 4+ years in supplier quality/quality engineering.
• Experience with medical/regulated environments preferred.

Responsibilities

• Lead, review and approve supplier change requests (SCR), Validation, TMV, PPAP, SCAPA, QMS.
• Develop and maintain Quality Plans, Control Plans, and FMEAs with suppliers.
• Work with CM/Suppliers to implement and sustain QA systems and activities.

Skills

Quality assurance

Supplier management

Statistical analysis

Documentation

Education

Bachelor’s degree

Tools

PPAP

FMEAs

QMS

Job description

Client of TTI (TAJ Technologies, Inc.)

JOB TITLE: Supplier Quality Engineer

LOCATION: North Haven, CT

DURATION OF PROJECT: 12 months or longer with possible extensions

Work Authorization:

Only Green Card holders and Citizens are eligible. No C2C or EAD-OPT candidates.

H1B transfer candidates are most welcome.

JOB SUMMARY:

Must hold a bachelor’s degree and require a minimum of 4+ years of experience.

Lead, support, review and approve supplier change request (SCR), Validation, TMV, PPAP, SCAPA, QMS etc.

Work with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities Quality Plans, Control Plans, and FMEAs.

Familiar with the Medical industry requirements such as ISO 13485, 21 CFR 820 standards etc.

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 requests, part/process qualification, manufacturing, QMS development, and technical quality/service/cost 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.

Responsibilities:

Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.

Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.

Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.

Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality