The Quality Control Supervisor/Engineer will lead incoming, in-process, final inspections to support product verification, data analysis, non-conformance investigations, instrument qualifications and other activities. The job will interface frequently with Manufacturing Engineering, Purchasing, Warehouse, Customer/Field Service, R&D, as well as external suppliers and contract manufactures. The successful candidate for this position takes pride in his/her hands-on and analytical abilities, organization skills, leaderships, and attention to detail.
Assist component, sub-assembly, and complete system inspections per applicable instructions, drawings, and specifications.
Manage daily quality control activities, ensure training, and serve as resource for technical/ administrative problems.
Maintain high-quality documentation on all inspection results.
Interface with Manufacturing Engineering to support in-line decision making.
Review Device History Records (DHR’s) and provide approvals/feedbacks to contract manufacture to support product drop shipments.
Identify quality issues, trend failure cases, summarize quality data, and provide regular reports for management review.
Participate in failure analysis and support implementation of corrective/preventive actions to resolve problems.
Initiate engineering change orders to update inspection procedures and create inspection plans.
Support internal/external audit program.
Coordinate with internal teams and external vendors to ensure all equipment calibration and preventive maintenance is in compliance.
Responsible for ESD floor/workstation testing and maintaining the ESD log
Bachelor’s degree in a technical field preferred or comparable experience.
Minimum five years’ experience in Quality Control. Medical device field preferred.
Experience with incoming, in process, finished goods inspection and DHR review
Experience updating procedures, documents, and inspection plans.
Strong verbal and written communication skills.
Experience using Microsoft Office, Oracle and Windchill
Experience inspecting Optics, PCBAs, Computers and Mechanical assemblies
Familiar with regulatory agencies: FDA’s (cGMP/QSR) and ISO 9001 / ISO13485.
Experience with managing people and providing leadership a plus