Must Have Technical/Functional Skills 50~70% work to be accomplished as per the requirement below:
• Use of electrical instruments, mechanical equipment, environmental chambers, hand tools, operating systems such as medical devices, Phaco console, Benchtop power supplies, DMM, laptop, cameras, drills.
• Ability to independently carry out tests in medical devices as per SOP.
• Capture test results in test book.
50~30% work to be accomplished as per the requirement below:
• Strong working knowledge of Document Control. Preferred platform Agile PLM.
• Hands on experience with: CO / MCO / CR processes
• Experience in quality or engineering documentation standards (ISO, FDA if applicable).
• Develop, document, and implement procedures to increase operational efficiency and quality.
• Implement, and maintain quality control systems, manuals, and procedures
• Analyze & identify bottlenecks or inefficiencies and recommend optimizations
• Define, implement, and monitor inspection methods and sampling plans.
• Excellent communication and cross functional coordination abilities.
• Strong analytical and documentation skills.
Roles & Responsibilities
Technician Responsibilities:
• Works under direct supervision and independently to construct & perform experiments, research and test activities related to product quality and reliability.
• Sets up, operates, and maintains mechanical and electronic laboratory instruments and equipment.
• Report and follow up on issues, progress and seek help when needed, document progress.
• Cleans and maintains laboratory equipment, tools, glassware, and lab areas.
• Maintains laboratory inventory of consumables.
• Interfaces with Metrology department and ensure that the calibrated instruments are properly documented and submitted for calibration on time.
• Use written material to help troubleshoot issues and perform tasks.
• Build test experiments and run test programs.
• Certification in soldering, crimping, electronics assembly, ESD, quality or reliability is nice to have.
• Experience with environmental temperature and humidity chambers or HALT chambers is a plus.
• Experience with Medical devices is a plus.
Document Control Responsibilities:
• Initiate Change Orders (COs), Manufacturing Change Orders (MCOs), Change Requests (CRs) in Agile PLM.
• Create, manage, and maintain document control procedures.
• Track and monitor change progress to ensure timely review and approval.
• Maintain compliance with company standards, documentation procedures, and regulatory requirements.
Salary Range $110,000-$120,000 years
TCS Employee Benefits Summary: Discretionary Annual Incentive. Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans. Family Support: Maternal & Parental Leaves. Insurance Options: Auto & Home Insurance, Identity Theft Protection. Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement. Time Off: Vacation, Time Off, Sick Leave & Holidays. Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.
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Computer Systems Support • Irvine, CA, United States
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