Quality Assurance Manager

Employer
IncellDx
Location
San Carlos, California
Salary
Up to $100,000 per year + beneits
Posted
May 19, 2021
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