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Senior Quality Engineer
hace 1 mes
Duties & Responsibilities
- Responsible for development and release of the quality design documentation, support team during design reviews and drive design history file compilation/audit activities.
- Leads design quality activities for new product development to deliver safe and effective products to the market by ensuring all aspects of design controls are robust and compliant to applicable regulations.
- Provide quality input to product user needs, design inputs, design specifications and design outputs (including analysis/definition of critical to quality features)
- Leads preparation for regulatory submissions and support sustaining quality with defending design control elements during audits. Includes leading design control gap assessments (DHF audits) and remediation as required.
- Support risk management planning, use/design failure mode effects analysis (FMEA), risk control and mitigation and verification of effectiveness.
- Works cross-functionally to influence key stakeholders and provides training, leadership, and mentorship to all team members.
- Creates and edits documents for the development and improvement on the Quality System.
- Performs data analysis and development of KPIs to identify required actions.
- Organizes and supports all audits.
- Provides guidance to staff by delivering courses or trainings.
- Performs as Quality Approver as required.
- Design and implement testing plans for products to ensure that all objectives are met.
- Identify procedures and scenarios for the quality control of products and services.
- Draft quality assurance policies and procedures.
- Support the applicable sites where the products are being designed and manufactured.
- Drive and participate in the Qualification Projects (Qualification Process, Test Method Validation, Inspection Method Validation, First Article Inspection, Vendor Qualification, Master Validation Plan, FMEA’s, Quality Plans, among others).
- In charge of Quality System activities as required (training, documentation, suppliers, others).
- Communicates product performance by formal presentations to management committees and design teams, supporting published product performance reports and supporting customer requests for performance information either directly or through the sales organization.
Required Qualifications:
- University degree on Engineering fields (e.g. Industrial, Mechanical, Chemical, other) or equivalent experience in Quality area or related field.
- Minimum 5 years of experience in Quality areas support. Experience with Medical Devices Research and Development and Manufacturing environment
- Knowledge of ISO 13485, FDA QSRs and EU MDR, other related regulations is a plus
- Experience managing QA Teams and projects
- Experience in quality inspection, auditing, and testing.
- Experience performing audits and quality certifications is a plus
- Strong analytical and problem-solving skills
- Creative and innovative thinker
- Time management, ability to plan and schedule multiple projects and tasks
- Meticulous attention to detail.
- Excellent verbal and technical writing communication skills
- English Advanced Level: written and spoken
Preferred Qualifications.
- ISO 14971
- Auditing (preferred)
- GD&T (preferred)
- Negotiation skills
- Licenses/ Certifications: Desirable, certification as Quality Engineer (ASQ CQE)
- Green Belt or Black Belt certification
- CQT (Certified Quality Technician), CQE (Certified Quality Engineer) or other certification related with quality field is a plus.
- Advanced statistical analysis skills.
Locations: San Jose, Cartago and Grecia, Costa Rica
Tipo de puesto: Tiempo completo, Permanente
Salario: ₡2,000,000.00 - ₡3,000,000.00 al mes
