Quality Assurance Specialist Job Vacancy in Epitope Diagnostics, Inc. San Diego, CA 92121 – Latest Jobs in San Diego, CA 92121 – updated today

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Company Name : Epitope Diagnostics, Inc.
Location : San Diego, CA 92121
Position : Quality Assurance Specialist

Job Description : Quality Assurance Specialist Qualifications:

Bachelor’s degree, biology or related field preferred but not required
Familiarity with cGMP, ISO 13485 requirements, FDA, and international quality
Computer skills

Duties and Responsibilities

Responsible for ISO 13485 audit, customer audit and US FDA audit
Stay current with all regulatory procedures and documentation in order to maintain compliance with GMP, QSRs, FDA, ISO, CE and customer requirements.
Develop procedures and practices to optimize product quality, safety, and reliability.
Work with Production and R&D to review and optimize or develop validation protocols.
Ensure compliance of product labeling and advertising.
Accomplish medical device quality assurance objectives.
Develops and updates quality assurance plans
Validates quality processes.
Maintains and improves product quality.
Prepares quality documentation and reports.

It is the policy of Epitope Diagnostics to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Epitope Diagnostics will provide reasonable accommodations for qualified individuals with disabilities.
Job Type: Full-time
Pay: $62,000.00 – $92,000.00 per year
Benefits:

Dental insurance
Flexible schedule
Health insurance
Paid time off

Schedule:

8 hour shift
Monday to Friday

COVID-19 considerations:Masks are required at workplace.
Work Location: One location

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