Sr Lead, Quality – CR

Job Description

• 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

1. In the process of obtaining a technical or university degree.
2. Basic written and verbal communication skills in English.
3. A minimum of three (3) years of experience in quality control in medical device
4. A minimum of two (2) years of experience as quality leader.
5. Clean room regulation handling regarding GDPs and GMPs.
6. Interpretation of drawings and their tolerances.
7. Intermediate use of Microsoft Office Suite.
8. Experience handling personnel and conflict solving abilities.
9. Knowledge of responsibilities to support the department.

1. 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.
2. Capable of receiving and giving instructions, and relating appropriately with the team, superiors, and support departments.
3. Experience in manufacturing medical devices using a microscope.
4. Skills and competencies for personnel management.
5. Comprehension of basic mathematics, specifications, percentages, reading and interpretation of drawings. Able to calculate basic indicators.
6. Management of basic measurement techniques such as scales, rulers and measurement system and their care. Able to explain the use and care of instruments.
7. Being a role model.
8. Ability to maintain confidentiality regarding relevant topics to the area.
9. Basic conflict management and problem solving skills. Timely escalation of conflicts to immediate leadership.
10. Proactive and analytical.

• Title: Sr Lead, Quality – CR