QA Specialist at Techtrueup

Santa Clara, California, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Sep, 26

Salary

0.0

Posted On

21 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Design History Files (DHF), Design Controls, Document Control, Change Control, CAPA, Nonconformance Investigations, Internal Audits, FDA Regulations, ISO 13485, Good Documentation Practices, Risk Management

Industry

Human Resources Services

Description

Company Description Fusion Life Sciences Technologies (www.fusionlifesolutions.com ) is a WBE-certified Healthcare Staffing and Engineering Services provider supporting industries including Pharma, Medical Devices, Aeronautical, Supply Chain, Heavy/Light Industrial, Food & Beverage, and Automotive. We proudly partner with 120+ clients such as Johnson & Johnson, Haemonetics, Delta, Caterpillar, Artisan Chef, Baxter, and many more. Our wide network of consultants and contract-to-hire engineers brings deep expertise across Engineering, Technical, Administrative, Healthcare, Life Sciences, Blue Collar, Skilled Trades, IT, Software Development, Manufacturing, and Supply Chain sectors. What sets us apart is our AI-powered, in-house software's enabling us to source and screen top talent within hours. This ensures rapid response times, high-quality matches, and virtually zero attrition. Job Description Job Title: Quality Assurance Specialist (QA Specialist) Location: Santa Clara, CA Duration: 6 Months Industry: Medical Device (Preferred) Experience: 2–4 Years Job Summary We are looking for a Quality Assurance Specialist with 2–4 years of experience to support quality system activities and maintain Design History Files (DHF) documentation. The ideal candidate will have experience in a regulated environment and a basic understanding of design controls and quality processes. Responsibilities Maintain and review Design History Files (DHF) and quality documentation. Support document control and change control activities. Assist with CAPA, nonconformance, and quality investigations. Review records to ensure compliance with company procedures and regulatory requirements. Support internal audits and quality system improvements. Collaborate with Engineering, Manufacturing, and Regulatory teams. Requirements Bachelor's degree in Engineering, Life Sciences, or a related field. 2–4 years of Quality Assurance experience in a regulated industry. Experience working with DHFs and design control documentation. Knowledge of FDA regulations, ISO 13485, and Good Documentation Practices. Strong attention to detail and organizational skills. Good written and verbal communication skills. Preferred: Medical device industry experience. Exposure to CAPA, change control, and risk management activities. Additional Information All your information will be kept confidential according to EEO guidelines.

Responsibilities

The role involves maintaining and reviewing Design History Files and quality documentation to ensure regulatory compliance. The specialist will also support CAPA, change control activities, and collaborate with Engineering and Manufacturing teams.