Description
Essential Duties and Responsibilities include but are not limited to: (Other duties may be assigned)- Generate/approve validation studies, capability studies, FMEA/Hazard analysis.
- Responsible for compliance to design control activities, environmental monitoring, sterilization validation, and shelf life requirements.
- Collaborate with engineering, manufacturing, and regulatory, and work with outside labs and suppliers.
- Support manufacturing operations in Costa Rica and provide expertise in statistical process control, min/max studies, and evaluation of control charts.
- Ensure that compliance to cGMP and EN/ISO 13485/MDD requirements are maintained.
- Ensure that all the responsibilities within the scope of this job comply with the scope of the company's Quality System.
Education and/or Experience:
- Requires a Bachelor's degree in engineering or life sciences.
- Minimum five years experience in the medical device industry.
- Must be able to make decisions related to product quality and release of the company's products.
- Requires ability to assess current practice with external standards, guidance, and regulations.
- Must be able to provide and implement solutions to quality problems.
- Requires the ability to understand the impact of GMP's, ISO 13485, and MDD requirements on the company's new products. CQE (ASQC) (recommended).
If interested in this position please forward me a copy of your resume and I will be in touch shortly.
To find out more about Real please visit www.realstaffing.com