Biocare Medical, LLC is an innovator in developing and supplying world class automated immunohistochemistry Instrumentation and the full range of reagents for immunohistochemistry and molecular lab testing. Biocare is the market leader in simultaneous Multiplex IHC tests which provide increased confidence at critical diagnostic decision points, impacting patient therapy while accelerating turnaround time.
The company’s customers include clinical histology laboratories, pharmaceutical companies, CROs, and biotechnology companies as well as academic, government, military, and other 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 and has a global distribution network.
This role is responsible for managing the people, processes, and tools in the Quality Assurance department. Develops, implements, maintains, and improves Biocare Medical’s Quality Management System (QMS). Responsible for core QMS processes such as CAPA, change management, documentation systems, management review, complaint investigation and closure, supplier quality management, distributor quality management, planned deviations, and audits management. Work cross functionally to collect data to track/trend and monitor the state of the QMS to assist in planning, defining, implementing, and tracking continuous improvement activities throughout the organization. Work together with the Quality Operations Manager to ensure adherence and compliance to Quality and Regulatory requirements.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Performs team management functions to include recruiting, performance management, and mentoring.
- Manages the QMS team’s tasks and assignments.
- Ensures the accuracy and completeness of the QA document control system.
- Coordinates the review and revision of procedures, specifications and forms as well as maintaining and updating the document control and tracking databases.
- Ensures that changes are documented and implemented.
- Coordinates Periodic Procedure Reviews to ensure documents are reviewed, as required.
- Notifies senior management of potential quality issues that might impact product quality.
- Reviews, tracks, closes, and trends compliance/quality issues related to customer complaint investigations.
- Monitors CAPAs to ensure that they are being opened, addressed adequately, and closed in a timely manner.
- Coordinates Quality Management Reviews and reporting.
- Manage the internal/external audit programs to ensure compliance with subject regulations. Setup back and front room and the logistics required for such audits. Perform internal audits.
- Manage the supplier Quality management process and supplier Quality agreements. Perform supplier audits.
- Assists in representing the company in ISO/FDA, notified body, and client audits.
- Track, implement, and monitor remediation activities resulting from audits.
- Prepares training presentations for training within the QA department as well as in other departments.
- Strengthens quality awareness, and actively works cross functionally to provide solutions to help support operational excellence.
- Identifies quality improvement opportunities, compliance concerns, identify, prevent, and resolve deviations.
- Manage the distributor Quality management process and distributor Quality agreements.
- Other duties as assigned by Management.
- Bachelor’s Degree with five to ten (5-10) years of management experience in Quality Assurance OR a combination of related experience and relevant advance education required.
- Leadership and team management experience, including the ability to motivate, mentor, and develop employees is required.
- Training/certification in ISO and GMP or certified auditor highly preferred.
- Proficient in quality management systems with experience supporting CAPA, change management, documentation control, complaints, management reviews, supplier quality management, and QA audits.
- Strong team player working across the organization promoting a quality culture.
- Excellent project management skills, attention to detail, and organizational skills.
- High level of reading comprehension.
- Ability to write clear & understandable documentation with effective presentation of information.
- Independent judgment within broadly defined policies.
- Extensive experience with ISO13485:2016/MDSAP, 21 CFR 820, IVDR/IVDD/cGMP, ISO14971:2019.
- Experience in electronic QMS and implementation is a plus.
- Advanced computer skills required.
- This is a full-time on-site position.
- 8 a.m. to 5 p.m. Monday – Friday. This position may require working extended weekday or weekend hours depending on business needs.
- $120,000 - $160,000 annually
- Company Sponsored Health Insurance - medical, dental, vision,
- Company Sponsored Life Insurance
- Voluntary Benefits
- Retirement plan - 401(k)
- PTO
- Paid Holidays
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.
Proof of at least one FDA EUA approved Vaccination for Covid-19 preferred. (Subject to reasonable accommodation)
All inquiries strictly confidential.
What We Do
Biocare Medical LLC is an innovator in automated immunohistochemistry (IHC) instrumentation, and the full range of reagents for IHC and in situ hybridization (ISH; RISH) testing. Biocare pioneered multiplex IHC detection which accelerates turnaround time, increases instrument productivity and reduces reagent consumption and cost by 50% or more.
Multiplex IHC allows pathologists to visualize more than one marker on a tissue at a time, allowing higher confidence for critical differentiation.
Biocare's intelliPATH FLX is the only completely open, continuous random access IHC instrument available.
The company’s customers come from clinical and research environments that do tissue based testing and include histology laboratories, pharmaceutical and biotechnology companies; CROs; and academic, government and military labs. Biocare Medical offers an expanding portfolio of products for the rapidly growing cancer and infectious disease diagnostic and research markets. Biocare medical is headquartered and has manufacturing facilities in Concord, Calif., and has a global distribution network. See biocare.net and slidestainer.com for more information.
NOTE: Biocare Medical, the Biocare Medical logo, and intelliPATH are trademarks of Biocare Medical LLC.
