Quality Assurance Engineer
Company: Cloud Talent
Location: San Jose
Posted on: November 23, 2021
Quality Assurance Engineer - Medical Device The Quality
Assurance Engineer will meaningfully contribute to all quality
assurance activities and provide support, resulting in continued
product improvement and compliance for advanced medical devices at
the forefront of cancer detection and therapy.
Provide support, continuous
improvement and implementation for all quality assurance activities
related to product development, product improvement, and
compliance. Maintain CAPA, complaints, and assist with document
control activities as required. Participate in Risk Assessments
that comply with ISO 14971:2019 Application of Risk Management.
Perform QC inspections of incoming parts and products as required.
Assist the Manager of Quality assurance in maintaining a quality
system that is compliant with FDA QSR and ISO 13485:2016 or any
other international regulations needed for company objectives Work
with the company to continually improve quality system and
procedures. Establish metrics to measure the quality of products
and processes Be an effective team player interfacing well with
R&D, Manufacturing Engineering, Manufacturing, Clinical,
Marketing and Sales Communicate on going quality assurance and
regulatory activities to the Manager of Quality Assurance. Assist
in preparation of annual Management Review Meeting metrics.
Successful management of
relationships at all levels of the organization including external
relationships with customers, and suppliers. Strong quality
engineering skills in utilizing quality science techniques such as
defect prevention, and process capability studies. Assist
engineering in the development of validation protocols, process
validation, inspection and test methods. Experience with IQ/OQ/PQ
validation of manufacturing processes. Experience in implementing
and maintaining quality systems per FDA QSR and ISO 13485 Must be
knowledgeable in EU MDD/MDR and MDSAP, regulatory requirements
Proficient MS Word, Excel, PowerPoint, Adobe Acrobat
BA/BS degree in life science,
bio-medical engineering or a related is preferred. An advanced
degree is a plus. Minimum of 5 plus years of experience in quality
assurance for medical devices. LOCATION:This position is remote 2
days/week and onsite in our San Jose, CA office 3 days/week.
Keywords: Cloud Talent, San Jose , Quality Assurance Engineer, Engineering , San Jose, California
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