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Restaurant Manager>
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Sous Chef
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Quality Supervisor - Santa Clara, United States - Aerotek
Description
Hiring an experienced Quality Supervisor for a Medical Device Company in Santa Clara, CA.
Position Overview
The Quality Control Supervisor will work on second shift. The Quality Control Supervisor plans and directs activities and personnel responsible for performing inspections/testing activities pertaining to Incoming Quality Assurance, In-process Subassemblies and Finished Goods, and Lot Release Testing. This role is required to work cross-functionally to resolve Production issues and provide QC support on cross-functional projects.
Essential Job Functions
• Supervise Quality Assurance activities required to support operations at SWMI.
• Mentor and support Quality Technicians
• Provide Quality Assurance leadership/guidance during investigation of issues pertaining to products and processes and will support the product launch, process validation, and continuous improvement activities in a cross-functional environment.
• Develop and initiate standards and methods for inspection, testing and evaluation.
• Assist in preparation of detailed inspection planning and instruction sheets.
• Coordinate with Quality Engineering and product engineers to determine inspection and testing needs.
• Train new technicians on processes and procedures on the use of specific gauges and measuring equipment, sampling, attribute and variable data recording, and records review.
• Generate detailed and accurate inspection and testing reports according to Current Good Manufacturing Practices (cGMP), and maintain inspection and testing files.
• Provide quality assurance leadership/guidance on projects while staying in compliance with FDA, ISO, EU, and other applicable medical device regulations as well as SWMI Quality System requirements.
• Lead/guide teams in conducting investigations related to non-conformances and/or customer complaints. Identify opportunities for process improvements.
• Implement improvements to inspection and test documentation, and quality system processes. Execute activities needed to support change control and documentation management processes.
• Lead/guide teams in preparing for internal and external audits and provide support for the execution of those audits. Assist with on-site or remote supplier audits as needed.
• Maintain QA related logs and databases (e.g. IQC, Equipment).
• Perform review of calibration certificates and support administration of the calibration system as needed.
• Perform QA related data entry and generate reports as required.
• Execute written protocols, gather data, and generate reports.
• Assist in identifying continuous improvement opportunities.
• Audit production lines to ensure QSR/GMP compliance as assigned.
• Maintain audit readiness of the Incoming Inspection, RMA and Calibration System and other areas of the QMS as assigned.
• Perform Sterile Load processing review, Device History Records review, and product release activities as assigned.
• Perform other QA related activities as assigned.
Logistics
About Aerotek:
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
