Quality Engineer - New London, United States - Carwild Corp

Carwild Corp New London, United States

Found in: Lensa US 4 C2 - 3 days ago

Description

Job DescriptionJob Description

The Quality Engineer will apply quality principles to address product and process issues, ensure reliable new and/or sustained product development, lead investigations, and provide general support of the quality system.

Responsibilities

Stay up-to-date and follow all Quality System and regulatory requirements for processes related to this job
Supports new, sustained product development and supplier related validation (IQ, OQ, PQ)
Act as a QA team representative for new design control projects
Responsible for managing complex complaint/quality investigations including but not limited to root cause analysis and corrective action
Responsible for risk analysis
Conduct and lead risk and safety.
Provide quality input/support for development of test/evaluation test protocols
Development of sampling plans for incoming inspection and production
Supports internal/external audits (FDA, ISO13485, Customers) assessments
Support with supplier development and qualification
Provides training support on key quality

management/assessment

tools, procedures, and specifications

Assist with preparation and filing of regulatory and quality documentation

2-5 years quality professional in a regulated industry

Experience working with ISO13485, ISO14971, and FDA 21 CFR Parts 820.

Minimum BS in Engineering or other technical field

Company DescriptionCarwild Corporation is a near shore contract manufacturer with more than 30 years of experience, specializing in medical absorbent technologies.

The company manufactures PVA and hydrophilic urethane foam, along with specialty medical-grade threads and dental floss. Converting capabilities include cotton, rayon, composite materials, assembly, die-cutting, sewing, sonic welding, and sterile packaging.

Company DescriptionCarwild Corporation is a near shore contract manufacturer with more than 30 years of experience, specializing in medical absorbent technologies.

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