Quality Engineer
katalyst healthcares life sciencesFoothill Ranch, CA
Quality Engineer
katalyst healthcares life sciencesFoothill Ranch, CA
today
Industries
Surgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingElectromedical and Electrotherapeutic Apparatus ManufacturingAbout the role
Quality Engineer We are seeking a Quality Engineer with experience in the Medical Device industry to support innovative healthcare products while collaborating with R&D, Regulatory, and cross-functional engineering teams. The ideal candidate will have strong knowledge of Medical Device Quality Engineering, ISO 13485, ISO 14971, Design Controls, Risk Management, Verification & Validation (V&V), Change Control, CAPA, GxP Compliance, and Product Development Support.
Roles & Responsibilities:
Support Medical Device Quality Engineering activities.
Collaborate with R&D, Regulatory, and cross-functional engineering teams.
Support Design Controls and Risk Management activities.
Participate in Verification & Validation (V&V) activities.
Support Change Control and CAPA processes.
Ensure compliance with GxP requirements.
Provide Product Development support.
Education & Experience:
Bachelor's degree in Engineering or a related field.2+ years of Medical Device Quality Engineering experience.
Strong knowledge of Design Controls, Risk Management, and Regulatory Compliance.
Excellent communication and problem-solving skills.
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JOB OVERVIEW
Experience level
Lead
Location
Foothill Ranch, CA
Occupation
Quality Control Systems Managers
Industry
Surgical and Medical Instrument Manufacturing
Posted
today
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