SUMMARY OF RESPONSIBILITIES:
Leads quality activities to support the lifecycle of the product. Develops, evaluates, and implements protocols/ methods to inspect and test in-process raw materials and finished while ensuring they are in compliance with both company quality assurance standards and applicable government regulations. Maintains knowledge of new developments and technology. Monitors products, processes, and projects within assigned product line and recommends changes to improve operating efficiency and quality
- Ensures compliance to in-house and external specifications and standards, such as current Good Manufacturing Practices (cGMPs) and International Organization for Standardization (ISO) regulations.
- Review production related inspection and data and recommends corrective actions and process improvements.
- Evaluates and analyzes the efforts in organizing, documenting, and interpreting inspection support documents and records.
- Ensures that established manufacturing inspection, sampling and statistical process control procedures are followed.
- Represents quality on various business teams to support product and process improvement.
- Represents quality during protocol development that ensures products and processes are designed, developed, transferred, and commercialized to meet appropriate regulations and business outcomes.
- Oversees Risk Management and provide input in design verification, design validation, shelf life studies.
- Provides technical guidance and training to other Regulatory Affairs employees and cross-functional teams.
- Develop and implement departmental and divisional procedures.
- Reviews and update Technical Files as required
- Performs Supplier Audits
- Helps with Product Registrations as required
- Coordinates Internal and External Audits, Findings and responses
- Oversees and support actions required for internal nonconformities such NCMRs, SCARs, CAPAs, Complaints, and Planned Deviations
- Supervises QC Inspectors II
- Helps with Calibration activities as required
- Conducts Training Program
- Review manufacturing processes and update the processes as necessary
- Other duties as assigned
QUALIFICATION REQUIREMENTS (EXPERIENCE, TRAINING, SKILLS, EDUCATION)
- BS in Engineering or equivalent
- Knowledge of QSR / ISO13485 / EN 46002 / MDD
- Preferred green belt or six sigma
- At least 5 years of experience
- Audit skills
- Statistical Knowledge
- Supervisory /Management skills.
- Communication, technical writing.
- Ability to work under minimal supervision and independently.
- Must be able to work in a timeline-driven environment.
- Ability to mentor and give work direction
PLEASE NOTE: This job requires job relocation to Santa Rosa California.