Quality Engineer, QA, IQ/OQ/PQ, software Validation, Medical Job in Houston 77023, Texas US
Skills Required:
Quality Engineer, software Validation,IQ/OQ/PQ, Medical, QA,Test Plan, ISO/QS
Job Description:
Quality Engineer – Software Validaion, Test Plan, QA/QC
Direct Hire/Perm
Houston, TX
We are currently looking for a Quality Engineer for a medical device/instrumentation firm. In this role, you will actively support Quality Assurance, Engineering and Manufacturing with inspection, qualification, verification and validation activities.
The ideally qualified candidate will bring will have the following experience and Qualifications:
• Education: Bachelors’ Degree, technical degree preferred.
• Experience: 1-2 years’ experience working within a Quality/Validation role and working within the medical device discipline and software space.
• We are looking for experience in software validation and someone who can also work as a repair engineer.
• Those with direct experience complying with the Medical Device Directive, ISO l3485 and FDA QSR.
•
This position will:
• Develop Quality Plans, generate and support IQ/OQ/PQ and validation protocols and reports.
• Review for completeness project plans, design control activities, labeling and technical documentation and Engineering Change Notices.
• Support Engineering and Manufacturing with testing activities to ensure product changes meet product and performance requirements.
• Analyze quality metrics to address process improvements with Manufacturing and Engineering.
• Assist with the development of and implementation of quality and manufacturing procedures.
• Develop and implement quality methods and equipment to improve effectiveness of test and inspection operations.
• Support new product development programs by providing input regarding Quality Assurance requirements early in the product development cycle.
• Work with all elements of Design Control, Process and Product Verification, Validation Testing including software validation, DMRs, and Risk Management.
Must be authorized to work in the United States on a full-time basis for any employer.
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