QUALITY ENGINEER

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 Incorporated is an exciting medical device startup company headquartered in San Jose, CA that is committed to bringing forward implantable medical device technology that will improve lives of patients battling with chronic illness.

PRIMARY FUNCTION

Quality engineering support for manufacturing operations, product returns, and supplier management activities. Key areas of support include incoming and in-process inspection, MRB, quality systems, and investigations of deficiencies/complaints. 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 departments 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
• Process returned materials and conduct investigations of device deficiencies/complaints
• Review changes in manufacturing processes and support process validation activities (IQ, OQ, PQ)
• Lead MRB activities to investigate nonconformances and identify root cause and corrective actions
• Initiate changes to improve quality systems and processes
• Conducts supplier qualification and maintenance activities
• Evaluate quality performance data and present results to the management team
• Other responsibilities as assigned

JOB REQUIREMENTS

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
• Basic understanding of the medical device industry including 21 CFR Part 820 and ISO 13485
• Basic understanding of mechanical, electrical, and/or software engineering
• Experience with the sterilization and statistical analysis
• 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

Compensation:

The base salary range for this position is $125,000-$145,000, plus bonus eligibility, equity, and benefits. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all locations. Within the range, individual pay is determined by factors including job-related skill level, work experience, relevant education or training, and location.

Work Environment:

• Office and laboratory
• Some travel necessary