Quality engineer

Position Summary
The CIS Quality Engineer supports complaint handling and post-market surveillance activities by executing signal evaluations, approving investigations, and ensuring compliance with corporate and regulatory standards. This role contributes to investigation quality, operational performance, and continuous improvement initiatives while developing technical expertise and cross-functional collaboration capabilities.

Key Responsibilities
• Approve complaint investigations aligned with quality and corporate expectations.
• Review completed returned product lab analysis, customer feedback and historical data to identify proper coding for product complaints.
• Analyzing post market surveillance data for patterns and trends and investigating when necessary. May be responsible for querying & bounding data to support implementation of document releases.
• Providing input for process improvement and helping develop tactical approaches to implement team strategies
• Maintain complaint backlog within defined performance targets.
• Lead assigned monthly complaint signal evaluations (SEF), coordinating with reviewers, approvers, and data analytics partners.
• Support SER/CRB activities by delivering required analyses and documentation on time.
• Execute and support NCEPs/CAPAs and complaint-related compliance activities.
• Contribute to Product Transfer Projects (PTPs), NPIs, and lifecycle initiatives as applicable.
• Act as product SME for less complex or well-established products.
• Participate in complaint reduction initiatives and continuous improvement efforts.
• Support development or execution of PMQA or divisional projects.

Performance Expectations
• Complete SEF evaluations within 30 calendar days with zero external audit findings.
• Maintain investigation approval and backlog targets aligned with corporate metrics.
• Ensure investigation quality supporting quarterly writing sampling expectations.
• Submit continuous improvement ideas and curiosity mindset contributions regularly.
• Develop or support at least one VIP annually.
• Complete assigned project deliverables within established timelines.
• Participate in at least one Diversity & Inclusion initiative annually.

Core Competencies
• Basic functional knowledge of complaint handling and regulated quality environments.
• Ability to execute root cause analysis and apply structured problem-solving tools with guidance.
• Data analysis and technical documentation skills. Knowledge in PowerBI, Power Automate is a Plus.
• Effective collaboration with cross-functional teams.
• Developing influence and communication skills.
• Strong Technical Writing skills.

Required Qualifications
• Bachelor’s degree in engineering, quality, electronic, biomedical engineering or any medical related field.
• Minimum 1 years' experience in quality, manufacturing or engineering roles or an equivalent combination of education and experience.
• Advanced English Level is a must
• Experience with the quality system escalations, NCEP/CAPA Investigations.

Profesional

Bachillerato universitario

Ingeniería Eléctrica - Electromecánica Electrónica y Mecatrónica

1 año de experiencia

1 Vacante