Quality Assurance Analyst (Medical Device & Biotechnology)

We bring you tomorrows 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 afull timeopportunity.

The ideal candidate will have:

• Bachelors 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 candidates 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 or call (866). 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.

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