Quality Process Engineer

Quality Process Engineer

Heraeus Medevio

Location Cartago

Permanent

Full Time

 

 

Responsibilities:

1. Develop and implement quality control plans and processes to ensure compliance with regulatory requirements.
2. Lead and oversee process improvement initiatives to enhance product quality, reduce defects, and optimize manufacturing processes.
3. Collaborate with cross-functional teams to identify and resolve quality issues and drive continuous improvement efforts.
4. Conduct root cause analysis and implement corrective and preventive actions to address quality non-conformances.
5. Perform risk assessments and develop risk mitigation strategies to ensure product safety and efficacy.
6. Provide training and guidance to production teams on quality control practices and procedures.
7. Monitor and analyze quality performance data to identify trends and opportunities for improvement.
8. Actively works within all aspects of the Quality System to provide supporting Value Stream Team.
9. Actively involved with Manufacturing/Engineering in the identification and resolution of product quality problems.

Qualifications:

1. Bachelor’s degree in engineering, Science, or a related field.
2. Knowledge of quality management systems, such as ISO 13485 and FDA standards, applicable to medical device manufacturing.
3. Experience with statistical analysis, process validation, and quality assurance methodologies.
4. Strong problem-solving and analytical skills, including familiarity with tools like FMEA, SPC, and DOE.
5. Excellent communication and interpersonal skills to collaborate effectively with internal and external stakeholders.
6. Excellent English Communications Skills
7. Understanding of risk management, CAPA processes, and regulatory compliance in the medical device industry.
8. ASQ certified Quality engineer a plus.
9. Ability to utilize MRP or ERP software and  Statistical Analysis Software.
10.  Root cause analysis training, Project Management, Statistical analysis, SPC, Six Sigma Tools  and Geometric Dimensioning and Tolerancing experience preferred.
11. Proficient with Microsoft Office. 

Candidates, interested in requisition in Quality Process Engineer, are invited to apply online or contact jobs-medevio@heraeus.com  for further questions – both will of course be treated confidentially.