Quality Engineer II

Quality Engineer II

6month initial contract/ temp to perm

8am-5pm

$44-$46/HR with health benefits

San Clemente, CA

Orion Group is seeking a Quality Engineer II to work onsite for our intravenous medical device manufacturer in San Clemente, CA.

The Quality Engineer is responsible for supporting Design validations and verification through adherence to design control and good documentation practice requirements.

Quality Engineer II Responsibilities:

• Gather and initiate main documents of DHF: Design Input, Design Output, Design V&V and Design changes
• Support and/or lead Risk Assessment (Risk Management Plan/Report, HA, UFMEA, DFMEA and PFMEA)
• Support R&D in collecting data of Remediation project
• Initiating testing protocols/reports
• Create and edit Design documents supporting technical Assessment, testing reports and Regulatory submission
• Build productive relationships internally and externally
• Work with R&D, Quality Engineers and Manufacturing Engineers on qualification of new or modified Design and Process
• Support initiatives for continuous quality improvements

Quality Engineer II Qualifications:

• Knowledge of the Medical Device Industry and familiarity with ISO and FDA QSR Regulations
• Proven knowledge in initiating/leading Risk Assessment (Risk Management Plan/Report, HA, UFMEA, DFMEA and PFMEA)
• Proven knowledge in structuring DHF
• Preferred knowledge in DOE, Process Capability, Gage R&R, etc
• Preferred knowledge in supporting Software development
• High Technical writing competency
• Bachelor's degree in Engineering or Technology
• 3-4 years experience in the Medical Device or Engineering Industry
• Design Quality experience required-protocols and reports as well as risk management files.
• ASQ certification would be preferred but not required

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.