Quality Assurance Specialist
hace 4 semanas
We are seeking a highly skilled Quality Assurance Specialist to join our team at K&Amp;I Healthcare Services Llc. The successful candidate will be responsible for ensuring the quality of our products and services, and will play a key role in maintaining our high standards of excellence.
Key Responsibilities- Develop and implement quality inspection procedures and test methods to support in-process and quality inspectors in manufacturing areas and functional testing labs.
- Coordinate and provide training on new or modified inspection procedures to ensure seamless implementation.
- Analyze and develop sampling plans to be used for inspection, utilizing corresponding AQL, RQL, and Cpk for attribute and variable data.
- Conduct audits of production processes to verify compliance with quality requirements as specified in procedures and process control plans.
- Participate in internal and external audit programs to ensure adherence to regulatory standards.
- Support the execution of validations of new processes, test methods, equipment, or products, including IQ, OQ, PQ, and TMV.
- Analyze defects and quality issues in production to identify trends and recommend corrective actions and/or changes to inspection criteria.
- Conduct statistical analysis and propose solutions based on results.
- Participate in multidisciplinary teams and projects for continuous improvement.
- Supervise inspection resources, including quality inspectors and auditors, as required.
- Lead multidisciplinary teams to implement improvements in manufacturing processes as required.
- Participate in the introduction and/or transfer of products or processes to the Tijuana plant.
- Support the investigation of customer complaints and establish improvements as required.
- Monitor quality metrics and take action as necessary.
- Manage the non-conforming material system, including material dispositions, support in containment actions, investigation, and corrective actions, and follow up on corrective actions to promote compliance with established activity dates.
- Advanced level of English proficiency.
- More than 2 years of experience in the quality department.
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