· Oversees the maintenance of the Quality Management System (QMS), FDA Regulatory and to assure that all documents, standard requirements, and defined processes comply with said standards.
· Conducting management reviews of the QMS as needed.
· Conduct training according to QMS requirements, including scheduling and record maintenance.
· This position is given the responsibility and authority to ensure that customer requirements are addressed.
· Ensure the calibration program according to the QMS requirements, including scheduling, equipment calibration/repair and record maintenance.
· Oversee internal auditing program meets the QMS requirements, including record maintenance.
· Ensure the CAPA (corrective/preventive action) program according to the QMS requirements, including following up, monitoring pending CAPA’s and record maintenance.
· Interface with customers on quality-related matters.
· Process and continuous improvement implementation with root cause resolution.
· Final inspections of the finished product to include participation in the inspection as well as training others in technical aspects of the inspection.
Determine and define quality assurance requirements by reviewing design specifications, industry standards, government specifications, or other applicable source documents.
· Formulate, write and maintain procedures, specifications and standards for the quality control of Seneca products including sampling and inspection methods, code base evaluation and visual acceptance standards.
· Develop and administer effective data collection and reporting system to meet regulatory requirements and management information needs, particularly in the defect management and complaints handling space.
· Control further processing, delivery, or use of nonconforming products until deficiency or unsatisfactory condition has been corrected.
Provides resources, including the assignment of trained personnel for performance of work and assessment activities to meet requirements.
· Manages trigger and trending, investigation, root cause identification, and VOE processes associated with CAPA, internal and external audit.
Implement systems in alignment with the corporate quality requirements, including CAPA, Supplier Quality, Complaint Handling, Management Review, Validation, and others as defined.
· Assesses emerging requirements for both the products and quality system relative to changing regulations, standards, and market expectations.
Experience:
- Bachelor's degree in a related field or equivalent experience
- 6-8 years of work experience in quality functions
- Proven experience in compliance, quality assurance, or a related field
- Strong knowledge of FDA regulations, CGMP standards, and quality assurance principles
- Experience with project management and the ability to manage multiple tasks simultaneously
- Familiarity with quality audits, QA/QC processes, and HACCP principles
-Experience in dealing with representatives from Food and Drug Administration or other regulatory agencies.
- Excellent analytical skills with the ability to analyze complex data sets
- Strong attention to detail and the ability to identify potential compliance issues
- Excellent communication skills, both written and verbal
Note: This job description is not intended to be all-inclusive.
The employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
Job Type: Full-time
Pay: $75,000.
00 - $100,000.
00 per year
Benefits:
* Dental insurance
* Flexible schedule
* Health insurance
* Life insurance
* Paid time off
* Vision insurance
Schedule:
* 8 hour shift
* Monday to Friday
Ability to Relocate:
* Durham, NC 27709: Relocate before starting work (Required)
Work Location: Hybrid remote in Durham, NC 27709
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