What are the responsibilities and job description for the Manufacturing Technician position at TekOne IT Services Pvt. Ltd.?
Role: Sr. Quality Technician
Location: Santa Clara, CA - 95054-2807
Duration: 12 Months
Shift Timings: 8 am to 5 pm
Description
Location: Santa Clara, CA - 95054-2807
Duration: 12 Months
Shift Timings: 8 am to 5 pm
Description
- Conduct functional testing as required by component drawings, manufacturing instructions, and/or test instructions
- Responsible for performing in-process and final components, subassembly and product inspection.
- Measure component dimensions per requirements or inspection plans.
- Records inspection and test data as prescribed by written instructions and procedures.
- Understand the capability of measuring tools. Utilize small hand-tools, calibrated instruments, measuring equipment, microscopes and test fixtures
- Understand material product specifications, engineering drawings and the requirements of the components and parts.
- Document non-conformance report once parts fail specifications or requirements.
- Recommend improvements to the production process to ensure quality control
- Responsible for completing documentation in a timely manner and in accordance with business standards;
- Foster the production team about quality control concerns to improve quality of the product.
- Maintain quality documentation in accordance with SOPs, WIs and GMP (CFRs)
- Resolve quality-related issues in a timely manner.
- Perform audits of manufacturing records during assembly to ensure compliance.
- Perform final manufacturing Device History Record (DHR) and Lot History Record (LHR) review at close of manufacturing process and product release
- Take appropriate action per procedural requirements and schedule when identify any potential nonconformance.
- Work with engineers and manufacturing to transfer technical information into easy to understand written form, as well as take a hands-on approach to learning and documenting the processes.
- Possesses a basic understanding of the Quality System, including Subsystems and is familiar with the Quality System Key processes.
- Adheres to a culture of continuous improvement.
- Supports engineering with documentation related tasks as required.
- Supports trending process and maintains Quality Records.
- Provide Quality support to key processes and product development/improvement projects.
- Adheres to Good Manufacturing Practices and Good Documentation Practices.
- Supports receiving inspection activities including but not limited to inspection and gathering all defined requirements and documentation to release parts/components.
- Supports Equipment Controls and calibration/PM activities including coordination with Calibration house, update Equipment log
- Keeps abreast of the standards that regulate our industry.
- Support other functional area as needed.
- High school diploma or equivalent qualification.
- 4 years’ experience working in manufacturing, or related field.
- Excellent knowledge of MS Office and Excel.
- Good math and technical skills.
- Strong understanding of quality control standards and testing techniques.
- Positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors.
- Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to maintain regular and predictable attendance.
- Very high level of attention to detail and accuracy.
- Excellent verbal and written communication skills.
- Ability to collaborate effectively.
- Must be an effective team player with the ability to train other technicians.
- 3 years prior medical device experience preferred.
