Quality Systems Coordinator

Our Company

Biocare Medical, LLC is an innovator in developing and supplying world class automated immunohistochemistry instrumentation, and the full range of reagents for IHC lab testing. Biocare specializes in high quality IHC, ISH, and FISH slide staining through its brand-new automated instrument, NeoPATH Pro™, and offers best-in-class simultaneous Multiplex IHC solutions.

The company’s customers include clinical histology laboratories, pharmaceutical companies, CROs, biotechnology companies as well as academic, government, military, and non-profit laboratories. Biocare Medical offers an expanding portfolio of integrated products to address the rapidly growing cancer and infectious disease diagnostic and research markets with novel tissue immunohistochemistry and in situ hybridization methods. Biocare Medical is headquartered and has manufacturing facilities in California with a global distribution network.

Summary/Objective

The Quality Systems Coordinator is responsible for maintaining and supporting the company’s Quality Management System (QMS), with a primary focus on document control and quality system records. This role ensures that quality documents—such as standard operating procedures, forms, and policies—are created, reviewed, approved, and maintained in accordance with internal procedures and applicable regulatory requirements (e.g., ISO 13485, MDSAP, FDA QSR, and EU IVDR). The coordinator also provides administrative support for QMS processes including change control, internal audits, and training records, and supports compliance activities such as CAPAs, nonconformances, and complaint handling. The ideal candidate will be detail-oriented, organized, and able to work collaboratively with cross-functional teams to uphold quality standards and regulatory compliance. This is an individual contributor role with no leadership responsibilities

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Maintain the Document Control System and support the overall Quality Management System (QMS) in accordance with applicable regulatory requirements (e.g., ISO 13485, MDSAP-participating countries, FDA Quality System Regulation, and EU IVDR), including the routing, approval, archival, and periodic review of controlled documents such as SOPs, forms, and policies.
• Coordinate and track document change requests in accordance with internal procedures and regulatory requirements (e.g., ISO 13485, MDSAP-participating countries, FDA Quality System Regulation, and EU IVDR).
• Support the administration and maintenance of document control systems, including PolicyTech, Tableau, Monday or similar platforms.
• Manage and monitor QA-Tickets, ensuring timely response and proper documentation of requests (e.g., document changes, process clarifications, quality queries).
• Ensure timely periodic review and update of controlled documents; issue reminders and track compliance across departments.
• Act as subject matter expert (SME) for document control processes and provide guidance and training to internal stakeholders.
• Assist in tracking and ensuring QMS conformance to maintain certification status with MDSAP and other relevant audits or inspections.
• Support quality system compliance activities such as CAPAs, nonconformances (NCs), and complaint investigations, under the direction of the Quality Compliance team.
• Prepare document control and QMS performance metrics; contribute to Management Reviews by providing data trends and summaries.
• Assist during internal and external audits (e.g., MDSAP, ISO, FDA) by organizing, retrieving, and verifying documentation and ensuring traceability.
• Collaborate cross-functionally to identify and implement improvements in documentation workflows and quality recordkeeping practices.
• Support onboarding and ongoing training of personnel in document control procedures and QMS-related software systems.
• Perform other duties as assigned to support Quality Assurance and regulatory compliance.
• Other duties as assigned by Management.

Competencies

• Associate’s or Bachelor’s degree in a life science, quality, or related field is required, or equivalent work experience in a regulated industry. 
• Working knowledge of QMS requirements for medical devices and IVDs, including document control, training, change control, and audit support.
• Strong accuracy and organizational skills for managing controlled documents and QMS records in a regulated environment.
• Able to understand and interpret quality procedures, regulatory requirements, and technical documentation.
• Skilled in writing and formatting SOPs, forms, and other controlled document