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.