Quality Control Technician Medical Device

Aviso, LLC; Fremont (CA); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

401(k)

Competitive salary

Dental insurance

Flexible schedule

Job summary

Aviso, LLC in Fremont, CA is seeking a Quality Assurance Technician focused on V&V and NPI to ensure product quality across the lifecycle, collaborating with Quality Engineering, Manufacturing, and R&D teams.

Responsibilities include executing tests per SOPs, logging deviations, supporting root-cause analyses, and drafting test reports, with ISO 13485 and FDA guidelines guiding all work. Excellent attention to detail and hands-on testing required.

Qualifications

• Associate degree in engineering, technical, or scientific discipline or equivalent experience.
• Minimum of 2 years in quality assurance, product testing, or manufacturing operations (medical device industry preferred).
• Solid understanding of ISO 13485 and FDA 21 CFR Part 820.
• Experience conducting test protocols and using laboratory measurement tools.
• Strong attention to detail and record-keeping; ability to read technical drawings and schematics.
• Experience with cross-functional collaboration and clear communication.

Responsibilities

• Perform functional, performance, and durability tests per approved SOPs.
• Configure testing hardware, fixtures, and samples as specified in SOPs.
• Document, process, and summarize test metrics following GDP.
• Log, report, and escalate deviations or out-of-spec findings promptly.
• Participate in root cause evaluations and failure investigations.
• Collaborate with R&D engineers to support prototypes and early-stage builds.
• Draft revisions for test procedures, work instructions, and inspection standards.

Skills

Attention to detail

Analytical mindset

Cross-functional collaboration

Strong communication

Education

Associate degree in engineering/technical/science

Tools

MS Excel

Test equipment

eQMS software

Job description

Benefits

• 401(k)
• Competitive salary
• Dental insurance
• Flexible schedule

Job Title: Quality Assurance Technician (V&V / NPI)

Role Summary

The Quality Assurance Technician plays a key role in maintaining product standards, focusing primarily on New Product Introduction (NPI) and Verification & Validation (V&V) activities. Collaborating closely with Quality Engineering, Manufacturing, and R&D teams, this position ensures all deliverables adhere to design specifications, industry regulations, and internal quality metrics across the entire product lifecycle.

Primary Responsibilities

V&V and NPI Operations

• Perform functional, performance, and durability test protocols according to approved methods.
• Configure testing hardware, custom fixtures, and sample units as specified in standard operating procedures.
• Document, process, and summarize test metrics following Good Documentation Practices (GDP).
• Log, report, and elevate test deviations or out-of-specification findings promptly.
• Participate in root cause evaluations and failure investigations.
• Work alongside R&D engineers to assemble prototypes, perform design iterations, and support early-stage build runs.
• Offer practical insights regarding quality concerns, testing feasibility, and design manufacturability.

Compliance & Continuous Improvement

• Conduct all testing operations in alignment with ISO 13485, FDA guidelines, and internal quality policies.
• Draft, organize, and archive complete test logs, technical reports, and trace records.
• Support document management by drafting revisions for test procedures, work instructions, and inspection standards.
• Tackle special projects and cross-functional quality tasks as assigned.

Qualifications

• Education & Background: Associate degree in an engineering, technical, or scientific discipline, or an equivalent mix of education and hands-on experience.
• Experience: Minimum of 2 years in quality assurance, product testing, or manufacturing operations (medical device industry strongly preferred).
• Regulatory Knowledge: Solid understanding of quality system regulations, specifically ISO 13485 or FDA 21 CFR Part 820.
• Technical Skills: Experience conducting test protocols, utilizing laboratory measurement tools, and working with basic data analysis tools (e.g., MS Excel).
• Quality & Detail Focus: Strong analytical mindset with rigorous attention to detail and record-keeping; ability to interpret technical drawings and schematics.
• Collaboration: Excellent interpersonal communication and cross-functional team skills.
• Bonus: Exposure to electronic Quality Management Systems (eQMS) software.

Working Conditions

Split between laboratory testing environments, production floor areas, and standard office spaces.

Requires occasional lifting, extended periods of standing, and direct operation of test equipment.