Quality Assurance Manager
- Employer
- IncellDx
- Location
- San Carlos, California
- Salary
- Up to $100,000 per year + beneits
- Start date
- May 19, 2021
View more
- Discipline
- Quality, Quality Assurance
- Required Education
- Bachelors Degree
- Position Type
- Full time
Essential job requirements
Establish and direct key quality system programs including, Corrective and Preventive Actions, non-Conformances, Complaints and Quality Audits
Assure that the finished products, processes, facilities and systems conform to ISO 13485, IVDR 2017/746 requirements and FDA QSR regulations
Review Device history Records and release products (Raw materials, Intermediate materials and Finished Goods).
Trend Quality indicators and lead continuous improvement of QMS
Act as Management Representative for quality management review meetings
Prepare and conduct management Review Meetings
Direct employee training program
Coordinate supplier qualification and performance reviews; write supplier Quality Agreements; perform supplier audits
Assure that the Equipment Calibration Program complies with the ISO and QSR requirements
Support method and equipment validation
Conduct internal audits as needed to monitor processes, facilities and systems
Review and approve Standards Operating Procedures, Manufacturing and Quality Control operating procedures
Review and approve reports and other documentation prepared to support product development and regulatory submissions/inspections
Provide Quality representation to project teams for products in development
Coordinate and manage Document Control Specialist and Quality Assurance Specialist
Qualifications
MS plus 2-5 years’ experience with In Vitro Diagnostic / medical Device
1-2 years’ of management experience
Good understanding of IVDR 2017/746, FDA QSR (cGMP), ISO 13485, and how to implement requirements based on standards
ISO 13485 and Lead Auditor certifications is preferred
Excellent written and verbal communication skills
Degree in biology, chemistry or related field
Highly detail-oriented, yet flexible.
Comfortable in a quick-paced environment, able to shift priorities when needed.
Work conditions and physical requirements
The work is performed indoors, in a general office environment and in a biology laboratory
Some tasks require the ability to work for extended periods of time on a computer
Some tasks require exposure to hazardous and/or toxic chemicals and potentially hazardous biological materials
Some tasks require the ability to lift up to 40lbs
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