Quality Process Engineer
Apply now »Date: Dec 14, 2024
Location: Cartago, Costa Rica, CR, 30106
Company: Heraeus
Quality Process Engineer
Heraeus Medevio
Location Cartago
Permanent
Full Time
Responsibilities:
- Develop and implement quality control plans and processes to ensure compliance with regulatory requirements.
- Lead and oversee process improvement initiatives to enhance product quality, reduce defects, and optimize manufacturing processes.
- Collaborate with cross-functional teams to identify and resolve quality issues and drive continuous improvement efforts.
- Conduct root cause analysis and implement corrective and preventive actions to address quality non-conformances.
- Perform risk assessments and develop risk mitigation strategies to ensure product safety and efficacy.
- Provide training and guidance to production teams on quality control practices and procedures.
- Monitor and analyze quality performance data to identify trends and opportunities for improvement.
- Actively works within all aspects of the Quality System to provide supporting Value Stream Team.
- Actively involved with Manufacturing/Engineering in the identification and resolution of product quality problems.
Qualifications:
- Bachelor’s degree in engineering, Science, or a related field.
- Knowledge of quality management systems, such as ISO 13485 and FDA standards, applicable to medical device manufacturing.
- Experience with statistical analysis, process validation, and quality assurance methodologies.
- Strong problem-solving and analytical skills, including familiarity with tools like FMEA, SPC, and DOE.
- Excellent communication and interpersonal skills to collaborate effectively with internal and external stakeholders.
- Excellent English Communications Skills
- Understanding of risk management, CAPA processes, and regulatory compliance in the medical device industry.
- ASQ certified Quality engineer a plus.
- Ability to utilize MRP or ERP software and Statistical Analysis Software.
- Root cause analysis training, Project Management, Statistical analysis, SPC, Six Sigma Tools and Geometric Dimensioning and Tolerancing experience preferred.
- Proficient with Microsoft Office.