Director, Quality Control
Carlsbad, CA 92008 US
This 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.
- 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
Regulatory Agencies/Customers – Interacts with regulatory agencies (FDA, ISO Registrar, etc.).
Manufacturing – Coordinates inspection activity, manages non-conforming material system and deviation system.
Engineering – Conducts technical failure analysis to resolve product, process, material or equipment related quality issues
R&D – Ensures QC resources and support for product development and product improvement projects
Supply Chain – Provides technical guidance and support for supplier, materials and compliance issues.
Facilities/Maintenance – Ensures facility/equipment functionality, calibration and safety through the interaction with mechanics on product quality and process improvement
Department Personnel – Mentors and develops personnel
Quality Assurance – Ensures compliance to all applicable standards, communicates any manufacturing/product issues and works together to ensure appropriate resolution
The work environment characteristics are representative of an office, laboratory, and manufacturing environment and may include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet project deadlines.
No strenuous physical activity, though occasional light lifting of files and related materials is required. 50% of time in meetings, working with team, or talking on the phone, 50% of the time at the desk on computer, doing analytical work. Walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Position requires the use of Personal Protective Equipment as posted.
EDUCATION, SKILLS & EXPERIENCE:
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
- 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
AFFIRMATIVE ACTION/EQUAL OPPORTUNITY STATEMENT:
Our company 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.
Please note that this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Salary: $175,000 - $190,000 This role is also bonus eligible, with a 25% target. This role is eligible for $65k in equity.