Quality Compliance Coordinator

Job Description

Job Description

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 Compliance Coordinator is responsible for the execution and oversight of quality event processes, including corrective and preventive actions (CAPA), deviations, nonconformances, and customer complaints. This role ensures that investigations are thoroughly documented, root causes identified, and appropriate actions implemented in accordance with regulatory requirements and internal procedures. In addition to managing quality events, the Quality Compliance Coordinator supports the Quality Management System (QMS) through assistance with document control, change management, audit readiness, and performance monitoring. This position helps maintain product and process integrity while driving a culture of continuous improvement and regulatory compliance across the organization.

Essential Functions

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

• Coordinate and support the management of CAPAs, deviations, and nonconformances, including documentation, root cause investigation, action tracking, and closure in compliance with regulatory requirements (e.g., ISO 13485, FDA QSR, MDSAP).
• Assist with customer complaint handling activities by managing documentation, facilitating investigations, and ensuring timely resolution with cross-functional involvement.
• Maintain accurate, audit-ready records for all quality events including CAPAs, deviations, nonconformances, and complaints.
• Support document control processes such as document formatting, routing, approval tracking, and archival to ensure compliance with internal procedures and applicable regulations.
• Manage the intake, tracking, and resolution of QA-Tickets related to document changes, quality inquiries, and system requests.
• Assist with change control activities, including preparation of documentation, risk evaluations, and follow-up to ensure timely and compliant implementation.
• Collaborate closely with Quality Systems Manager and other stakeholders (Regulatory Affairs, Operations, R&D) to support investigations and quality system improvements.
• Support internal and external audit activities by preparing quality event documentation, retrieving controlled documents, and assisting with audit responses.
• Contribute to the collection and reporting of QMS metrics such as CAPA status, complaint trends, and document control performance indicators.
• Promote quality awareness and contribute to continuous improvement initiatives across the organization.
• Perform additional quality system support duties as assigned to maintain effective regulatory compliance and operational excellence.
• 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.
• Experience with investigation tools (e.g., 5 Whys, Fishbone/Ishikawa, Root Cause Analysis).
• Strong understanding of quality event processes (CAPA, complaints, deviations, nonconformances).
• Experienced in electronic QMS platforms (e.g., Monday, Tableau, PolicyTech, MasterControl) for tracking complaints, CAPAs, NCs, and quality documents.
• Familiar with FDA QSR, ISO 13485, MDSAP, ISO 14971, and EU IVDR as they apply to QMS maintenance and document control.
• Works effectively across departments to ensure documentation compliance and support quality system activities.
• Professional, clear, and calm in handling escalated complaints and quality events.
• Effectively manages multiple priorities, deadlines, and projects to maintain QMS integrity and meet business needs.

Compensation Range

• $28 - $33 Hourly

Expected Hours of Work

• 8:00 a.m. to 5:00 p.m. Monday – Friday. This position may require extended weekday or weekend hours depending on business needs.

Full-Time Positions Offer

• Company Sponsored Health Insurance - Medical, Dental, Vision
• Company Sponsored Life Insurance
• Voluntary Benefits
• Retirement plan with a match - 401(k)
• PTO
• Paid Holidays
• EAP

BioCare Medical values the diversity of individuals, ideas, and perspectives, and what they bring to the workplace. We know that our people represent the future of the company, so we only hire the best from around the world. Applications from all qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, physical or mental disability, or status as a Protected Veteran.

All inquiries strictly confidential.