Supplier Quality Engineer - SQE - Medical Device / Plastic Injection Molding

Great Opportunity - make a significant impact with a growing company!

Our client is a total plastics contract manufacturer and product design company. They specialize in manufacturing complex, high-precision injection molded components and assemblies. They embraced a Total Quality Management approach to business with a strong focus on Technology, Teamwork and Solutions.

Our client’s team is a best-in-class blend of mold and engineering expertise, skilled mold making, a thorough knowledge of engineering thermoplastics processing, and a high-level service and quality awareness. They are seeking to add to their team to ensure they give each client the best the industry has to offer.

Key Duties:

Srategic sourcing, managing supplier relationships, supply chain security, supplier measurement, supplier contracts, and supplier pricing for the supply base within plastics, electronics, electro-mechanical assemblies and raw materials.

RESPONSIBILITIES

Primary responsibility is to assist in the development and management of the overall supplier quality for new, line extension and existing products. This includes supplier quality engineering oversight, quality systems implementation including test and inspection plans and product reliability, supplier audits, risk management and design transfer while working with Regulatory Affairs Department to ensure compliance to FDA Quality System Regulations and ISO 13485.
Supplier Development Technical / Process: May Assist or lead supplier development initiatives and is a technical resource for the materials, operations, quality, R&D and supplier management teams with regards to supplier quality, supplier development and supplier process evaluation.
Facilitates Early Supplier Involvement and Design For Manufacturability and Assembly (DFMA).
Helps develop Supplier Quality Plans. Assists materials and operations teams developing and reviewing supplier contracts and approval.
Participates and helps design, manufacturing and quality engineers in Supplier Selection during New Product Development process. Reviews and assists in the Materials review of the PPQA process.
Assist or leads reviews of operating procedures to ensure GMP and ISO 13485 compliance.
Participant and/or champion for Corrective Action and Preventative Action (CAPA) process.

QUALIFICATIONS

Bachelors Degree in Business, Engineering, Supply Chain or related field
Minimum of 5 years experience in procurement of direct materials.
Previous experience with medical devices and plastic injection molding desired
Commodity Specific Technical Expertise (PCBA, Wire Harnesses, Machining, Sheet Metal, Molded Plastics, and OEM)
Knowledge of Six Sigma tools & methodologies, with proven ability to apply them
Supplier Audit and or Lead Assessor Experience
Knowledge of Quality System Standards QSR, ISO3485
In exchange for your expertise, they offer a challenging, fast-paced work environment that supports continuous improvement processes & lean manufacturing principles. They offer an attractive total compensation package where high performance and success are fostered and rewarded.

If you seek an opportunity where your talents can be celebrated, partner with other passionate players that are hungry to make an impact, and achieve superior results? We need you!


Apply Online Today



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