Overview
Quality Engineer Jobs in San Jose, California, USA at Neuspera Medical Inc.
Neuspera Medical Inc. is looking for a Quality Engineer in San Jose, CA.
This local job opportunity with   is live since :54:23.
Location: Neuspera Medical, Inc. headquarters in San Jose, CA
Reporting to: Director of Quality
JOB SNAPSHOT
Base Pay: Negotiable
Employment Type: Full-Time
Job Type: Engineering
Education: 4 Year Degree
Experience: Minimum 3 years
Manages Others: No
Industry: Medical Devices
Required Travel: Occasional
ABOUT NEUSPERA MEDICAL, INC.
Neuspera Medical, Inc. is an exciting early-stage medical device company with a uniquely positioned neuromodulation technology platform, headquartered in San Jose, CA. Neuspera is committed to developing implantable medical device technology that will improve the lives of patients battling chronic illness.
PRIMARY FUNCTION
Quality Engineer supporting manufacturing operations and design transfer. Key areas of support include incoming and in-process inspection, MRB, quality systems, process validations, and test method validation. This position is expected to take a hands-on approach on all aspects of quality engineering and quality systems.
JOB DUTIES
Work with Manufacturing, R&D, Regulatory, and Clinical to meet clinical and commercial milestones
Provide daily quality support to incoming inspection and manufacturing activities
Review and monitor processes for Receiving and In-Process Inspection, Calibration / Preventive Maintenance, Nonconforming Materials, Product Testing, and Finished Goods Release
Maintain quality system and participate in internal/external audits to ensure compliance with FDA regulations and ISO 13485
Review investigations of device deficiencies/complaints
Review changes in manufacturing processes and support process validation activities (IQ, OQ, PQ)
Collaborate with engineers to evaluate and validate applicable test methods
Lead MRB activities to investigate nonconformances and identify root cause and corrective actions
Initiate changes to improve quality systems and processes
Conduct supplier qualification and maintenance activities
Evaluate quality performance data and present results to the management team
Other responsibilities as assigned
JOB REQUIREMENTS
Basic understanding of the medical device industry including 21 CFR Part 820 and ISO 13485
Basic understanding of mechanical and/or electrical engineering
Experience with sterilization and statistical analysis
QUALIFICATIONS AND EXPERIENCE
Bachelor’s degree in Engineering, Science or similar field
Results driven, collaborative team player capable of working well with others, as well as autonomously with little direction
Ability to adapt to dynamic situations and adjust as we grow
Experience with software validations a plus
COMPENSATION
Based on market data and other factors, the salary range for this position is $100,000 – $125,000. However, a salary higher or lower than this range may be appropriate for a candidate whose qualifications differ meaningfully from those listed in the job description.
WORK ENVIRONMENT
Office and laboratory
Some travel necessary
Foster work culture of diversity and inclusion, honesty and integrity, accountability and teamwork, proactive communication focused on results that is based on facts and is respectful
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Title: Quality Engineer
Company: Neuspera Medical Inc.
Location: San Jose, California, USA
Category: Quality Assurance – QA/QC, Engineering
