Biology Job USA | Quality Director Position @ Singulex: Singulex is a commercial stage, privately held company pioneering Next Generation immunodiagnostics (NGI). Singulex’s provides unprecedented ultra-sensitivity in the precision measurement of biomarkers. Such reliable ultra-sensitive accuracy provides definitive health status answers for physicians and patients resulting in improved health outcomes and reduced healthcare cost, without reducing delivery of care. The company’s NGI commercial offerings are transforming patient care from reactive disease treatment to proactive health management.
Biology Job USA | Quality Director Position @ Singulex
The ideal candidate for this position would have extensive experience implementing and managing quality systems for medical devices in conformance with ISO 13485 and 21 CFR 820 requirements. Additionally, the candidate would demonstrate strong leadership skills and experience bringing medical device product(s) through the design control process from feasibility to launch.
- BS/BA degree in Science or related field
- 10+ years related QA and Quality Systems experience
- Strong understanding of QSR and ISO regulatory requirements
- Demonstrated proficiency with Excel, PowerPoint, and Word programs
- Must have excellent written and verbal communication skills and the ability to understand, prepare, and communicate technical information
Essential Duties and Responsibilities
- Develop and implement Quality System SOPs and processes to achieve ISO 13485 and 21 CFR 820 compliance
- Provide value added recommendations for financial performance improvements
- Support on-site audits by our customers and regulatory agencies
- Design, compile, analyze, trends and issue QA performance metrics reports
- Perform other duties as assigned.
Singulex provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. Singulex expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status.