Quality Manager

About us

Trace-Ability (www.TraceAbilityInc.com)has developed and launched a groundbreaking product in close collaboration with the FDA called Tracer-QC. It provides complete automation of quality control (QC) for radio-pharmaceuticals with unprecedented simplicity enabled by patented reagent kits. The product is on the market with rapidly growing demand. Trace-Ability is expanding to meet the business objectives and achieve the vision of Tracer-QC becoming the gold standard recognized by the industry and expected by FDA inspectors. Achievement of this vision will translate into patient outcomes (in oncology, neurology and cardiology) relying on broad availability of a diverse range of radiopharmaceuticals enabled by our product.

Job Title: Quality Manager

We are seeking a highly motivated and experienced Quality Manager to join our team. As our Quality Manager, you will interface with cross functional management and team members. Your role will involve creating, implementing, and upholding quality systems, programs, policies, processes, procedures, and controls that comply with ISO standards, FDA regulations, and customer requirements. You will ensure the quality of the delivered product meets specification. This position requires extensive experience of working collaboratively alongside with suppliers, customers, and Production/PD/R&D teams to develop and implement Quality improvement programs.

Key Qualifications

• Develops, implements, communicates and maintains a Quality plan to ensure the Company’s processes meet established requirements
• Understands to a high level all operational phases of the company to better implement new programs and manage all process controls effectively
• Promotes quality achievement and performance improvement throughout the organization
• Monitoring performance by gathering relevant data and producing statistical reports
• Respond to customer’s correspondence concerning quality issues
• Monitor and maintain procedures and documentation for product recall and tracking
• Lead, manage, coach, mentor, and train all Quality Control Supervisors and Technicians within the group.
• Manage CAPA processes; assure root cause analysis and effectively implement robust CAPA in a timely manner. Follow-up and verification of CAPAs to assure no recurrence. Adhere to corporate escalation and reporting guidelines
• Provides oversight for implementing the Quality Management System (QMS) and resources to meet ISO 9001-2015 requirements.
• Work closely with key RND, Production, and Engineering personnel to support testing, troubleshooting and driving continuous improvements

Requirements

• Bachelor of Science in Chemistry, biochemistry, biology, or a related field
• Minimum of 4 years’ experience in a leadership role in a prior Quality Manager role
• Ability to successfully lead and develop a team.
• Trained in Quality Management System (QMS) and the ISO 9001-2015 process
• Technical, Analytical skills and business knowledge

Job Type: Full-time

Pay: $90,000.00 - $150,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Van Nuys, CA 91406: Reliably commute or planning to relocate before starting work (Preferred)

Experience:

• Quality assurance: 3 years (Preferred)
• Quality systems: 2 years (Preferred)
• ISO 9001: 3 years (Preferred)

Work Location: One location

Salary : $90,000 - $150,000