Sr Supplier Quality Engineer

1 month ago


Lafayette, United States ATR International Full time

Help streamline and speed our time to market and build quality in at every step You will be a member of the Released Product Engineering team that supports the design, development, and maintenance of innovative, new medical device products, as well as commercially released products within the Advanced Surgical Technologies business You can apply advanced technical concepts to complex problems throughout the product life cycle.

In this role, you will work as part of a team, providing technical support on New Product Development and Sustaining Project Initiatives, ensuring medical devices are designed with the utmost regards to safety, reliability and quality You will be responsible for reviewing supplier documentation including First Article Inspection Reports and OQ/PQ documentation and assisting with new component supplier qualifications with help from the Released Product Engineering team.

A Day in the Life
Ensures that suppliers deliver quality parts, materials, and services.
Qualifies suppliers according to company standards
Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
Provides technical guidance and quality compliance for Supplier Quality engagement throughout the lifecycle on newly qualified parts and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy and Control Plans for new components.

Requirement:

The ideal candidate will possess the following qualifications:

Must Haves:
Bachelor's degree and a minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.
Product Part Approval Process Experience
Understanding of IQ, OQ, PQ
Molding Experience
Understanding of GD&T

Nice to Have
Degree in Engineering or Scientific discipline
CAD Experience
Detail-oriented with strong commitment to quality and to the workplace.
Excellent analytical, organizational, and communication skills Strong ability to work with multidisciplinary and global teams.
High tolerance for change, and ability to multi-task continuously.
Strong negotiation, conflict management, and influence management skills.
Experience in the medical device industry.

These are the Must Have's:
•Product Part Approval Process Experience
•Advanced Understanding of IQ, OQ, PQ
•Molding Experience
•Understanding of GD&T
•Experience using statistical techniques like process capability

Education Required: Bachelor's Degree in Engineering

Years' Experience Required: Minimum of 4 years of relevant experience

Must Have
Advanced understanding and application of GD&T (Geometric Dimensioning and Tolerancing).
Authored Performance Qualification Protocol
Created Installation Qualification and Operational qualification
develop injection molding
Production Part Approval Process Training

Nice To Have
3D CAD/ Design Engineer

Benefits:

Benefits include:
-MEC/ACP Medical
-Voluntary Dental, Vision, Life, Supplemental Income
-401k (must meet requirements)
-sick leave as required by state/county



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