About this role
Quality Analyst
Volt takes great care of our great hires
Volt is immediately hiring for a Quality Analyst in Pacheco, California
Shifts available: Mon- Fri 1st Shift
Contract- 12 Months, Full time
As a Quality Analyst, you will:
Responsibilities
- Assist with Nonconformance and customer complaint handling activities by managing documentation, facilitating investigations, and ensuring timely resolution with cross-functional involvement.
- Support effective inter/intra departmental collaboration for overall document control activities supporting IVDR remediation and key performance indicators.
- Maintain accurate, audit-ready records for all quality events including Change control, CAPAs, deviations, nonconformations, and complaints.
- Support document control processes such as document formatting, routing, approval tracking, and archival in alignment with compliance requirements set forth in internal procedures and applicable regulations.
- Support Internal QA ticketing system execution to triage open action items within Quality Department.
- Assist with change control activities, including preparation of documentation, risk evaluations, and follow-up to ensure timely completion.
- Supports internal/external audits to ensure compliance with subject regulations and supports finding closures efficiently.
- Prepares and provides Training for Quality processes related to quality management system as necessary
- Maintains and tracks QMS programs as necessary, including facilitating the progress of deliverables, KPI Reporting, conducting trending analysis, and communicating quality compliance issues.
Qualifications & Preferred Skills:
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Bachelor's degree in science, or related field (or equivalent experience)
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2-4 years of experience in Biotechnology quality assurance and/or medical device industry is a plus.
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Intermediate understanding of QA methodologies.
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ISO13485, ISO14971, 21CFR 820, IVDR and Quality Management regulations
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Experience with Quality Management System tools (e.g., Electronic Documentation systems)
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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).
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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 contact the company.
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Volt does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with applicable laws.