Senior Design Quality Engineer

Descripción y detalle de las actividades

The Senior Design Quality Engineer ensures that compliance to customer, risk management, quality, and Design Control requirements is demonstrated and helps to ensure successful transfer of the design to manufacturing. They are responsible for accurate generation and evaluation of Design History File documentation and Quality System compliance.

**Essential Job Functions and Responsibilities**

- Provide technical and statistical reliability support to Product Development, Manufacturing and Quality organizations
- Assist with efforts to resolve advanced technical and Quality-related problems
- Contribute to New Product Introduction Projects as a core team member and communicate activities to the team members of Quality
- Support transfer activities by developing and executing the transfer validation strategy
- Support the product development teams in the adoption and use of best practices, Quality tools-Design Control methodologies
- Leads root cause investigation using Lean Principles and Tools
- Perform Risk Analysis including Fault Tree Analysis (FTA), Human Factors/Usability, and Failure Mode and Effects Analysis (FMEA) activities to ensure risks are identified and addressed
- Monitor and develop reliability improvements to existing & new designs
- Support Post Market Surveillance in the investigation of product complaints to determine the root cause and recommend appropriate corrective and preventive action to prevent recurrence
- Support supplier development and continuous improvements; monitoring supplier performance, KPI’s, implementing corrections, and audits
- Support verifications for cost, quality, and capacity initiatives.
- Report on achievement of targets and identify any actions required
- Work with other Groups to maintain an approved internal Quality System that meets the requirements of GMP’s, QSR 21 CFR Part 820 and ISO 13485
- Evaluate quality data and prepare reports to monitor trends
- Generate and approve Engineering & Development Change Orders
- Support internal/external audits

Experiencia y requisitos

**Required Qualifications**

- Bachelor’s degree in Engineering or Science (or similar) is required. Master’s degree is preferred.
- Minimum of 7 years of hands-on experience in the Quality Engineering discipline.
- Prior experiences in the medical device field is required; preferably experience with Capital Equipment and single use medical devices.
- Knowledge of FDA Quality System requirements, ISO 13485 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
- Must be able to communicate fluently in both written and spoken English

**Desired Qualifications**

- Ability to work effectively in a fast paced and dynamic environment.
- A self-starter, motivated and able to positively motivate others.
- Focused, target driven with a positive, can-do attitude.
- Drive to assigned objectives which delivers best practice results, added value and continuous improvements across the business and quality management system.
- Leadership and interpersonal skills to develop and manage good working relationships with internal departments (manufacturing, receiving, purchasing, product development, and regulatory), contractors, and suppliers.
- Strong written and verbal communication skills.
- Certified Quality Engineer a plus.
- Lead Auditor certification a plus.
- Lean Certification a plus.
- Experience with statistical analysis software a plus

Beneficios

- Beneficios de acuerdo a la LFT
- seguro de vida
- bonos anuales
- caja de ahorro
- comedor
- transporte
- seguro de gastos médicos
- plan de indexación

**Número de vacantes** 1

**Área** Calidad

**Contrato** Permanente

**Modalidad** Híbrido

**Turno** Diurno

**Jornada** Tiempo Completo

**Estudios** Carrera con título profesional

**Inglés** Hablado: Avanzado, Escrito: Avanzado

**Disponibilidad p. viajar** No