About this role
Sr Lead, Quality – CR
Job Description: Coordinate quality activities with medium supervision to ensure that materials, documents, and processes fulfill the company’s established procedures and practices. Actively participate in product quality supervision. Support the quality supervisor / manager in different task and take part in continuous analysis, research, and improvement and events when required. Job duties: • Direct and coordinate Quality Control Inspection on the performance of in-process and final product inspection. • Understand instructions for product inspection documents: QS, WI, PDs. • Expert in line inspection and certified according to the assigned responsibility by the supervisor. • Execute additional tasks related to the tasks assigned by the quality control supervisor / manager. • Assure in-process and final product inspection training is performed. • Understand and implement Good Practices Documentation (GDPs) and Good Manufacturing Practices (GMPs); responsible for updating metrics, follow-up, and presenting improvement actions. • Ensure the quality inspections maintain the equipment requirements and evaluate new equipment and techniques. • Direct and coordinate to train on good documentation practices. • Responsible for controlling daily individual inspectors’ goals in production and quality areas, as well as supporting the supervisor or manager when necessary. • Support the absent supervisor by keeping track of the actions and task department. • Contribute daily with necessary reports to assurance the KPIs metrics compliance. • Capable of detecting and implementing improvement ideas to reduce bottlenecks, and perform line balances to ensure compliance of production goals. • Evaluate the quality Inspection resources needed for product transfers, increase, or ramps. • Ensure compliance with the safety guidelines of the area and reporting incidents, acts and unsafe conditions. • Coordinate and analyze the necessary resources to carry out special production requirements seeking to minimize the impact on production KPIs. • Escalate and propose solutions to the supervisor and manager regarding both detected and potential non-conformances. • Responsible for coordinating and ensuring the correct procedure for the training of the personnel in charge, according to the requested needs. • Ensure daily compliance with the disciplinary matrix. • Provide support to quality engineering with NCR opening and investigations. • Coordinate human resources activities according to their position and personnel in charge. • Perform additional duties as assigned.
Qualifications: • In the process of obtaining a technical or university degree. • Basic written and verbal communication skills in English. • A minimum of three (3) years of experience in quality control in medical device • A minimum of two (2) years of experience as quality leader. • Clean room regulation handling regarding GDPs and GMPs. • Interpretation of drawings and their tolerances. • Intermediate use of Microsoft Office Suite. • Experience handling personnel and conflict solving abilities. • Knowledge of responsibilities to support the department. Desired Qualifications • Efficient and effective written and verbal communication skills; the ability to follow and explain the procedures (QS, WIs, PDs) of the company according to their position and their personnel in charge. • Capable of receiving and giving instructions, and relating appropriately with the team, superiors, and support departments. • Experience in manufacturing medical devices using a microscope. • Skills and competencies for personnel management. • Comprehension of basic mathematics, specifications, percentages, reading and interpretation of drawings. Able to calculate basic indicators. • Management of basic measurement techniques such as scales, rulers and measurement system and their care. Able to explain the use and care of instruments. • Being a role model. • Ability to maintain confidentiality regarding relevant topics to the area. • Basic conflict management and problem solving skills. Timely escalation of conflicts to immediate leadership. • Proactive and analytical.