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Technology Consultant
Pacheco, CA

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VOLT

Quality Assurance Analyst (Medical Device & Biotechnology)

Job Description

We bring you tomorrow's opportunity, today Volt is immediately hiring for Quality Assurance Analyst (Medical Device & Biotechnology) in Pacheco, CA 94553. As a Quality Assurance Analyst, you will: Support nonconformance investigations, customer complaints, and corrective action activities. Maintain audit-ready documentation for CAPAs, deviations, change controls, complaints, and nonconformances. Support Quality Management System (QMS) processes and KPI reporting. Manage document control activities, including formatting, routing, approvals, tracking, and archival. Assist with IVDR remediation projects and regulatory compliance initiatives. Support internal QA ticket management and follow-up on quality action items. Participate in change control activities, risk assessments, and documentation reviews. Assist with internal and external audits and support timely closure of audit findings. Deliver training on quality system processes and compliance requirements. Analyze quality metrics and trends, identify risks, and communicate compliance issues to stakeholders. This is a full time opportunity.

The ideal candidate will have:

Bachelor's degree in Science, Biology, Biotechnology, Engineering, or a related field, or equivalent experience. 2-4 years of experience in Quality Assurance within the Medical Device, Biotechnology, Life Sciences, or regulated manufacturing industry. Working knowledge of Quality Management Systems (QMS).

Experience with:
ISO 13485 ISO 14971 FDA 21 CFR

Part 820 IVDR regulations CAPA and Change Control processes Electronic document management systems Strong organizational, analytical, and documentation skills. Ability to work effectively in cross-functional teams and manage multiple priorities.

Pay Rate:

$32.00 - $37.64 per hour.

•Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Qualified candidates should

APPLY NOW

for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.

Benefits:

Volt offers benefits (based on eligibility) that include the following: health, dental, vision, term life, short term disability, AD&D, 401(k), Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP). Volt is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Volt is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please email hr_dept@volt.com or call (866) -898-0005. Please indicate the specifics of the assistance needed. Volt does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from VOLT and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at volt-information-sciences-privacy-policy.pdf #ZRV

Benefits

  • Paid Time Off (PTO)
  • Sick Leave
  • 401(k) Plans
  • Health and Wellness Programs