Design Quality Engineer
hace 2 meses
Work Environment: Hybrid
Location: Heredia, Costa Rica
About the Role:
As a Design Quality Engineer in our hybrid team, you will provide pre-market and post-market design quality assurance support to ensure the delivery of high-quality products to our customers.
Your Responsibilities:
- Represent the division on global quality system improvement projects, soliciting input from stakeholders and advocating for the needs of the engineering team.
- Own quality system NCEPs, CAPAs, and project plans related to design assurance and risk management.
- Apply sound problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
- Collaborate with internal customers on related processes such as management review, design controls, risk management, cybersecurity, and post-market surveillance.
- Comply with all corporate and applicable regulations related to complaint investigation management.
- Monitor regulatory submission and audit questions, communicating lessons learned to internal customers and assisting teams with response writing.
- Supervise and support the design quality assurance team in activities related to PDP projects.
- Assist with engineering evaluations and updates of procedures.
Requirements:
- Bachelor's degree or above in a STEM-related field.
- At least 7 years of experience in a similar position.
- English language proficiency: C1 level (90-94%).
- Desirable knowledge: Formal training in statistical and quality techniques, ASQ certification.
- Experience in managing regulations and complaints, MDR / MDV.
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