Scope:
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.
Responsibilities:
- 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
Requirements/Qualifications:
- 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
