Quality Assurance Associate 1

Quality Assurance Associate 1 (Dublin / Pleasanton / Livermore)

Diagnostic BioSystems, Inc. is an FDA registered, cGMP compliant, ISO13485:2016 certified, manufacturer of products for the pathology, histology, and cancer research markers. DBS was founded in 1994 and is based in Pleasanton, California, USA. We distribute products in the domestic as well as in the international markets.

Diagnostic BioSystems, Inc. (DBS) is a leading provider of innovative in vitro diagnostic (IVD) solutions specializing in immunohistochemistry (IHC), molecular diagnostics, and assay development for pathology laboratories worldwide. Our mission is to enhance diagnostic accuracy through cutting-edge technologies, high-quality reagents, and compliance with global regulatory standards.

Position Summary:

The QA Associate I plays an important role in maintaining and improving the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, IVDR (EU 2017/746), and other applicable regulatory standards. This role involves supporting QA processes such as document control, external/internal audit support, CAPA management, NCR management, complaint handling and assisting in regulatory compliance efforts.

Key Responsibilities:

Quality Management System (QMS) Support:

• Maintain and ensure compliance with ISO 13485:2016, FDA QSR (21 CFR Part 820), and IVDR.
• Assist in document control processes, including revision, distribution, and archival of Standard Operating Procedures (SOPs), work instructions, and records.
• Support internal and external audits (FDA, Notified Body, ISO, and customer audits) by preparing documentation and responding to audit findings.
• Track and follow up on Corrective and Preventive Actions (CAPAs), Non-Conformance Reports (NCRs), and Deviations.

Product and Process Compliance:

• Ensure compliance with Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).

Training and Continuous Improvement:

• Maintain employee training records and track training compliance.
• Provide QA support for product development and manufacturing teams.

Qualifications & Experience:

Education & Experience:

• Bachelor’s degree in Biology, Chemistry, Biochemistry, Biomedical Engineering, or a related field preferred.
• 1–3 years of experience in a Quality Assurance role within the IVD, medical device, or biotechnology industry.
• Familiarity with ISO 13485, FDA QSR (21 CFR Part 820), and IVDR (EU 2017/746).

Technical Skills & Competencies:

• Experience with eQMS platforms (e.g., Veeva, MasterControl, Greenlight Guru, or similar) preferred.
• Knowledge of document control and CAPA management
• Strong understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Proficiency in Microsoft Office (Excel, Word, PowerPoint) and ability to handle electronic quality systems.

Soft Skills:

• Strong attention to detail and organizational skills.
• Excellent verbal and written communication skills.
• Ability to work independently and within a cross-functional team.
• Problem-solving mindset with the ability to analyze data and identify trends.

Why Join Diagnostic BioSystems, Inc.?

• Be part of a growing, innovative IVD company that impacts global diagnostics.
• Work with a collaborative and dynamic team in a regulated and high-quality environment.

Gain hands-on experience in regulatory compliance, quality systems, and process improvements

Job Type: Full-time

Pay: $45,000.00 - $55,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Education:

• Bachelor's (Required)

Experience:

• Quality assurance: 2 years (Required)

Language:

• English (Required)

Work Location: In person

Salary : $45,000 - $55,000