Quality Supervisor II

Description

About us:

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

Position Summary

The Quality Supervisor II is responsible for leading and supervising the day-to-day operations of the Quality area, ensuring compliance with regulatory requirements, corporate standards, and customer expectations. This position directs and develops Quality personnel, coordinates inspection and product release activities, monitors process performance through quality indicators, and promotes continuous improvement initiatives to ensure the effectiveness of the Quality Management System.

He works closely with Production, Engineering, Supply Chain, and other support functions to ensure quality targets, operational continuity, and customer satisfaction are met.

Key Responsibilities

Leadership and Personnel Management

• Supervise, guide and develop Quality personnel, including inspectors, technicians and other assigned resources.
• Manage the department's resource allocation, work priorities, and operational coverage.
• Perform performance evaluations, monitoring objectives and individual development plans for the personnel in charge.
• Identify training needs and ensure compliance with team training requirements.
• Participate in the processes of recruitment, selection, incorporation and retention of talent.
• Promote a culture of quality, compliance, teamwork and continuous improvement.
  
  

Quality Operations

• Coordinate and prioritize daily Quality Control activities to support manufacturing programs and business objectives.
• Provide quality support to Production and Engineering for problem solving and process improvement.
• Supervise the inspection activities of reception, process and finished product as applicable.
• Ensure timely review and release of manufacturing records (DHR) in accordance with regulatory and Good Documentation Practices requirements.
• Support the review and implementation of inspection plans, control plans, and other quality controls.
• Ensure the proper management and disposal of non-conforming materials.
• Participate in product and process transfer activities from development to manufacturing.
• Provide technical leadership to the manufacturing area on issues related to quality and compliance.
  
  

Quality and Compliance Management System

• Ensure compliance with internal procedures, regulatory requirements, and applicable standards of the medical device industry.
• Participate in investigations of non-conformities, complaints, CAPA and deviations, ensuring the timely execution of corrective and preventive actions.
• Support the development, review and implementation of procedures and work instructions related to the Quality Management System.
• Actively participate in internal audits, corporate audits, customer audits, and regulatory audits.
• Follow up on audit findings and verify the effective implementation of committed actions.
• Timely escalate quality, compliance, or potential customer impact risks.
  
  

Metrics and Continuous Improvement

• Monitor key quality indicators (KPIs) and communicate results to Quality Management.
• Analyze quality trends and identify opportunities for improvement in processes and systems.
• Support continuous improvement initiatives using statistical tools and problem-solving methodologies.
• Monitor the monitoring of inspection indicators, defects, rework, waste and non-conforming material events.
• Participate in the implementation and maintenance of statistical process control (SPC) tools when applicable.
• Recommend improvements in equipment, inspection methods, and processes to increase operational efficiency and effectiveness.
  
  

Administrative Responsibilities

• Manage and approve records of attendance, vacation, and other administrative processes of assigned personnel.
• Keep the indicators, records and documentation applicable to the area updated.
• Ensure compliance with safety, occupational health and corporate policy requirements.
• Perform other related functions as assigned by Management.
  
  

Must Have

• A Bachelors degree in a STEM related field.
• 3 to 5 years of experience in engineering or manufacturing processes, preferably in the medical device industry.
• Minimum 2 years of experience leading or supervising technical or professional personnel.
• Intermediate to advanced English, with the ability to participate in meetings, audits, documentation review and communication with global teams.
• Experience in the Medical Device industry.
• Experience in non-conformance management, CAPA, audits and continuous improvement initiatives.
• Knowledge of quality management systems under ISO 13485 and applicable regulations for medical devices.
• Knowledge of problem-solving techniques, root cause analysis, and statistical tools.
• Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Knowledge of CPS, control plans and continuous improvement methodologies.
• Experience with ERP, PLM or quality management software systems is desirable.
• It must be fluent in computer systems for data analysis, specifically Microsoft Office.
• Must possess good verbal communication, organizational, and management skills.
• Experience in supervision and development of work teams, with leadership skills, effective communication, conflict resolution and performance monitoring.
  
  

Good To Have

• They must be able to implement quality programs, interpret the data collected and present them to management to facilitate continuous improvement.
  
  

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec’s goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.