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 Senior Quality Engineer is responsible for ensuring ongoing compliance with product quality standards, regulatory requirements (ISO 13485, FDA 21 CFR Part 820), and operational objectives on medical device assembly lines. They lead the management of non-conformities, process validation projects, risk analysis, and corrective and preventive actions (CAPA), serving as a key technical liaison with external auditors, customers, and multidisciplinary engineering and production teams.

Essential Job Duties and Responsibilities

- Production Floor Monitoring: Actively supervise assembly lines to ensure strict adherence to Standard Operating Procedures (SOPs), control plans, and product specifications within a controlled environment/cleanroom.
- Non-Conforming Material Management: Evaluate, disposition, and coordinate the immediate containment of non-conforming components or assemblies via NCMR/RNC reports.
- Operational Meetings (Gemba / Daily Tier): Participate in daily production reviews to monitor key quality metrics (First Pass Yield, scrap, defects per million/DPPM) and coordinate immediate containment actions.
- DHR Review and Release: Audit and validate Device History Records (DHR) for the release of finished product lots for sterilization or distribution.
- Line Issue Support: Provide immediate technical support to quality inspectors and line technicians regarding quality incidents or deviations during the assembly process.
- Quality Management System (QMS): Maintain, improve, and ensure compliance with the QMS under ISO 13485, FDA Quality System Regulation (21 CFR Part 820), and applicable regulations (MDR / COFEPRIS).
- CAPA and Problem Solving: Lead in-depth root cause investigations for internal non-conformities, field failures, and customer complaints using structured methodologies (8Ds, 5 Whys, Ishikawa, DMAIC).
- Process and Method Validation: Develop, review,



and execute validation protocols and reports for assembly processes (IQ, OQ, PQ) and test method validations (TMV / Gauge R&R;).
- Risk Management: Create and update Process Failure Mode and Effects Analysis (PFMEA) and associated control plans in accordance with ISO 14971.
- Engineering Change Management (ECO/ECN): Assess quality and regulatory impacts of modifications to designs, materials, equipment, or assembly processes.
- Audits: Serve as an internal auditor and represent the Quality Department during audits by customers, Notified Bodies (BSI, TÜV, etc.), and regulatory agencies (FDA).
- Supplier Quality Development: Collaborate with Supplier Quality on assembly component evaluations, supplier audits, and investigations into failures attributable to raw materials.
- Mentorship: Guide and train quality engineers, technicians, and inspectors on quality tools and medical regulatory standards.

Education and Experience Requirements

Education: Completed university degree in Industrial, Mechatronics, Biomedical, Mechanical, or Chemical Engineering, or a related field (Professional license/registration mandatory).

Work Experience: Minimum of 5–8 years of progressive experience in quality engineering within the medical device manufacturing industry (manual, semi-automated, and automated assembly processes).

Languages: Advanced English (verbal and written fluency for interaction with corporate, clients, and international auditors).

Desirable Certifications

- ASQ Certification as Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA).
- Six Sigma Green Belt or Black Belt certification.
- Certified Internal Auditor for ISO 13485 / FDA QSR.

Mandatory Regulatory Knowledge

- ISO 13485
- FDA 21 CFR Part 820
- ISO 14971




- Labeling and traceability regulations (UDI).

Preferred Skills and Abilities

Technical Skills: Advanced proficiency in Core Tools: Statistical Process Control (SPC), APQP, PPAP, MSA, and FMEA. Proficiency in statistical software (Minitab) for process capability analysis (Cp, Cpk), Design of Experiments (DOE), and hypothesis testing. Advanced interpretation of engineering drawings, dimensional tolerances, and GD&T; specifications. Proficiency in ERP/MES systems (SAP, Oracle, Camstar) and quality document management software (MasterControl, Arena, TrackWise).

Interpersonal and Leadership Skills: Rigorous analytical thinking and attention to detail. Situational leadership and the ability to make critical decisions under pressure (e.g., line stoppage due to quality risk). Assertive communication and inter-departmental negotiation (Production, Manufacturing Engineering, Regulatory Affairs). Project management and time management.

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.

#J-18808-Ljbffr

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