Job description
Quidel’s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world. We are a leading manufacturer of point of care diagnostic solutions. Quidel’s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19.
We are excited to announce that Quidel Corporation is now becoming QuidelOrtho! This transaction will bring together two world-class teams and complementary product portfolios to serve patients around the world. During this transition period, we encourage you to continue visiting our career site and also check out more career opportunities at Careers at Ortho Clinical Diagnostics | Ortho Clinical Diagnostics jobs Join our journey as we become one global diagnostics leader!
The Director, Quality Control is responsible for managing the quality control department functions, which include receiving inspection, in-process inspection, finished goods inspection, QC Chemistry and instrumentation triage. In addition, this position is responsible for directing, implementing, and continuously improving the quality controls and processes associated with manufacturing, returned goods, preventative and corrective actions, non-conforming materials, and inspection control plans. The Director, Quality Control also actively supports corporate strategic goals and objectives through manufacturing support, process improvement projects, and product development/ product improvement projects. This role acts as the primary operations liaison between manufacturing and QA/QS and ensures operations execution within the QA/QS requirements.
ESSENTIAL FUNCTIONS:
- Leads efforts in managing the nonconforming material, process deviations, biological raw material testing, stability programs and customer complaint investigation functions
- Manages effective quality control systems through the identification, segregation, root cause analysis, corrective action, disposition and trending of product and process failures and inefficiencies
- Manages the expired materials control system to minimize scrap and maintain compliance
- Reviews material specifications, development of supplier/material qualification plans, and generation of inspection control plans
- Provides support to manufacturing in proactive resolution of quality issues, root cause failure analysis and troubleshooting
- Manages all aspects of manufacturing acceptance, in-process controls, DHRs batch record review, release of finished goods and intermediates
- Assures product traceability and record retention
- Leads departmental activities in significantly reducing product rejection, scrap and variances
- Works proactively with the operations staff to identify and correct quality problems with products and processes
EDUCATION AND EXPERIENCE
- Bachelor of Science or equivalent work experience and technical certification required
- 10+ years of progressive QC Management responsibility
- 8+ years of leadership experience preferred
- Medical device experience preferred
- Working knowledge of ISO 14385 Regulations, or some similar quality regulated quality system required
- Experience in a high-volume manufacturing environment preferred
- Experience with statistical techniques and Design of Experiment (DOE) required
KNOWLEDGE/SKILLS:
- Quality Tools – Problem Solving / Statistical Process Control / Process Capability / ISO 14385 / Design of Experiments / Sampling Plans / Root Cause Analysis
- Managerial Skills – Employee & Team Development / Career Development / Cost Accounting
- Excellent Communication Skills
- Advanced computer skills
- Project management skills
Before you apply, please make sure you share Quidel’ s values. We pride ourselves on keeping these values in mind every day as we execute on goals and plan for the future. We are seeking employees who share the same mindset and commitment to be
customer driven,
focused on execution, and
new product oriented. We succeed by being
determined,
optimistic team players.
Quidel is proud to be an Affirmative Action/Equal Opportunity Employer (Minorities/Women/Disabled/Veterans). We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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