Drive quality at the heart of innovation—partner directly with software engineers developing life-changing diagnostic technology.
This is a high-impact, hands-on Quality Assurance role supporting software-based product development at a small, R&D-focused site. The ideal candidate brings deep expertise in medical device or diagnostic regulations, thrives in design control environments, and enjoys mentoring teams while owning documentation review and approval from start to finish.
Quality Assurance Engineer IV
Location: San Jose, CA (Hybrid – approximately 50% onsite) Contract Duration: August 31, 2025 – December 30, 2025 Industry: Medical Device / Diagnostics Job Type: Contract (Potential for Full-Time Conversion) Compensation: Up to $132.53/hr (W2, all-inclusive)
Key Responsibilities:
Serve as the primary QA reviewer and approver for design documentation (requirements, risk assessments, test plans, CAPA)
Lead activities related to design control, change control, and risk management
Provide hands-on mentorship to software engineers and cross-functional team members
Maintain Design History Files (DHF) and ensure compliance with FDA QSR, ISO 13485, IVDR, and MDSAP
Support internal audits and external inspections
Utilize Helix ALM for requirement and test traceability
Required Qualifications:
10–15 years of Quality Assurance experience in medical device or diagnostics
Extensive experience with design control, risk management, and regulatory compliance
Comfortable reviewing and approving documentation independently
Confident mentoring R&D and software development teams on quality standards
Familiarity with FDA QSR, ISO 13485, MDSAP, IVDR
Proficiency with Helix ALM or comparable traceability tools
Preferred Qualifications:
QA experience supporting regulated software development
Agile development exposure
Certifications such as CQE, CSQE, CQA, or Six Sigma Black Belt
Additional Details:
Small R&D site focused on a single product (no manufacturing onsite)
Manager prefers higher onsite presence early in the contract
Minimal travel (5% or less)
Conversion to full-time possible with budget approval
This role is perfect for a senior QA professional ready to lead from the front—technically sharp, regulatory fluent, and confident guiding others through complex quality landscapes.
Pay Details: $80.00 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.pdstech.com/candidate-privacy
The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
The California Fair Chance Act
Los Angeles City Fair Chance Ordinance
Los Angeles County Fair Chance Ordinance for Employers
San Francisco Fair Chance Ordinance
Job Number:
US_EN_33_022202_2427735
Job Location:
San Jose, CA
Rate:
80
Per Diem:
--
Overtime:
--
Duration:
indef
Start Date:
ASAP
Input Date:
07/18/2025
Last Updated:
07/19/2025
Firm Name:
PDS TECH COMMERCIAL, INC
Attention: Address:
545 E JOHN CARPENTER FWY STE 950
City, State:
IRVING, TX 75062
Phone:
214/647-9600
800 Phone:
800/270-4737
Email:Client.Services@pdstech.com Website:Go To PDS Tech Commercial Website
