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Quality Engineer - Medical Device

Company: Aerotek
Location: San Clemente
Posted on: August 26, 2020

Job Description:

Global Medical Device company specializing in life saving, life enhancing IV therapy products, systems, and services is seeking two Quality Engineers to support their team in South Orange County.

Duties:

Initiate and manage main documents of DHF: Design Input, Design Output, Design V&V and Design change

Work with R&D in collecting and managing data of Remediation project

Work with R&D on creating Design V&V protocols and reports

Manage and initiate Accelerated Aging protocols/reports & support Sterility studies

Create and edit Design documents supporting technical Assessment, testing reports and Regulatory submissions

Manage Risk & lead Risk Assessment (HA, DFMEA, PFMEA, etc.)

Work with R&D, Quality Engineers and Manufacturing Engineers on qualification of new and modified Design

Ensure the readiness of internal and/or external audits including the support as Audit Prescriber

Manage continuous improvement projects

Build productive relationships internally and externally

Qualifications:

Proven knowledge of the Medical Device Industry and hands on experience in ISO and FDA QSR Regulations

Experience in creating Design V&V protocols and reports

Strong experiences in initiating and managing Risk Management documents (HA, DFMEA, PFMEA, etc.)

Familiarity of international regulations such as REACH and RoHS compliances

Experience in investigations, risk assessments and associated CAPA activities

Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.) is preferred

Skills in Quality compliance, audit and investigation

Detail oriented and critical thinker characteristics are required

High verbal and Technical writing competencies

Bachelor's Degree in Engineering, Biomedical, or Life Sciences field

Knowledge of statistics, laboratory equipment, processes and procedures

Knowledge of materials (emphasis on medical plastics) and medical device manufacturing practices

Must possess excellent computer skills and ability to document test protocols and complete test reports

Pay Rate: $45-$55 per hour

For immediate consideration, please contact Kai Chauncey at (714) 347-1221

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing ® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

Keywords: Aerotek, San Clemente , Quality Engineer - Medical Device, Other , San Clemente, California

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