Our Culture

We strive for an inclusive company culture, where everyone feels valued, has a voice and is treated fairly, for their personal benefit, the benefit of Quasar, and the benefit of our customers and doctors using our products for patients in need.

Job Summary

The Quality Engineering Supervisor is responsible for leading, coordinating, and ensuring compliance with product quality and quality management system standards on medical device assembly lines. They ensure that manufacturing processes strictly adhere to current international regulations (ISO 13485, FDA 21 CFR Part 820 / QMSR, and ISO 14971), lead root cause investigations, and drive continuous product and process improvement.

Essential Job Duties and Responsibilities

- Supervision and prioritization: Direct the daily activities of quality engineers and technicians assigned to medical assembly lines.
- Non-Conformance (NCR) and CAPA management: Identify, document, and oversee the containment and investigation of non-conforming materials or products on the shop floor; coordinate the timely execution and closure of Corrective and Preventive Actions (CAPA).
- Production metric monitoring: Evaluate daily quality metrics such as First Pass Yield (FPY), scrap levels, rework, and defect trends.
- Direct manufacturing floor support: Address line stoppages due to quality discrepancies, assessing potential product impact and authorizing technical material dispositions.
- In-process control verification: Ensure the correct application of inspection plans and statistical sampling (AQL/ANSI/ASQ Z1.4), as well as the timely and accurate completion of Device History Records (DHR).
- Root cause analysis: Facilitate and lead daily/weekly problem-solving sessions using structured methodologies (5 Whys, Ishikawa Diagram, 8Ds).
- Regulatory Compliance and Audits: Ensure the department's ongoing adherence to ISO 13485, FDA QMSR, and ISO 14971 standards. Act as the auditee/technical host during internal, customer, and Notified Body (TÜV, BSI, FDA) audits.




- Process and Facility Validations: Review and approve validation protocols and reports for equipment and processes (IQ/OQ/PQ), as well as software or Test Method Validation (TMV).
- Process Risk Management: Develop, update, and maintain Process Failure Mode and Effects Analyses (PFMEA) and Product Control Plans, ensuring alignment with ISO 14971 risk management requirements.
- Change Control (ECO/DCN): Evaluate the impact of design, component, or assembly process changes on product quality prior to shop-floor implementation.
- Staff Development and Leadership: Evaluate performance, identify training needs, define development plans, and maintain up-to-date regulatory training records for the team.
- Customer Complaint Management: Coordinate technical investigations arising from market complaints or product returns, implementing actions to prevent recurrence.

Education and Experience Requirements

- Education: University degree (Degree and Professional License): Industrial, Mechatronics, Biomedical, Chemical, or Mechanical Engineering, or a related discipline.
- English and Spanish: Advanced level. Bilingual for audits and corporate interaction.
- General experience: Minimum of 4–6 years of experience in Quality Engineering within the medical device or pharmaceutical manufacturing industry.
- Leadership experience: At least 2 years serving as a Supervisor, Team Leader, or Senior Quality Engineer with direct reports.
- Desirable Certifications: Certified Quality Engineer (CQE – ASQ) or Certified Quality Auditor (CQA). Lean Six Sigma certification: Green Belt or Black Belt. ISO 13485 Lead Auditor or Internal Auditor.





Preferred Skills and Abilities

- Skills: Medical Standards: ISO 13485, FDA 21 CFR Part 820 / QMSR, ISO 14971. Quality Tools: APQP, PPAP, PFMEA, Control Plans, SPC (Statistical Process Control). Validations: IQ, OQ, PQ, TMV, Cleaning and Sterility (as applicable). Data Analysis: Intermediate/advanced proficiency in Minitab, analytical Excel, and ERP systems (SAP, Oracle).
- Abilities: Team leadership: Personnel management, delegation, and talent development. Critical decision-making: Objective assessment of patient/product risks under pressure. Effective negotiation between production and quality compliance. Assertive communication: Fluid presentation of metrics and executive reports.

Working Conditions and Physical Demands

While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate. Controlled Environment and office area.

Join Our Integral Team

Are you passionate about helping others? Our employees are dedicated to serving medical device customers who deliver life-giving therapies around the world. We seek individuals who are enthusiastic, intelligent and thrive in teamwork, with a strong aspiration to pursue a fulfilling and impactful career. At Quasar, every day is a new opportunity to make a difference.

True To Quality

At Quasar, quality is more than just a priority – it is part of our culture. Our comprehensive development and manufacturing solutions for minimally invasive devices, catheters and sensors enable life-giving therapies for patients all over the world, and we take this responsibility seriously.

Our Mission

To earn the trust of leading medical device brands as quality supply partner with minimally invasive and innovative solutions for patients globally and locally. What we make saves lives. If you share our commitment to quality and innovation, we want to hear from you.

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📌 Supervisor, Quality Engineering (México)
🏢 Quasar Medical Tecate S.A. de
📍 México