Quality Engineer

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. 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.]]>