Description
Job Functions:- Apply ISO, FDA and other applicable guidelines to the biological analysis of medical instrumentation and surgical products.
- Actively support and advise on new product development activities.
- Lead and participate in the development and improvement of processes for existing and new products.
- Support the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ).
- Review/approve nonconforming material and system documentation.
Job Requirements:
- Bachelors degree in Microbiology, Biology or related field
- 4+ years industry specific experience- Medical Device
- knowledge of a variety of microbiological concepts, practices, and procedures.
- Demonstrated knowledge of sterilization techniques- ETO, STEAM, GAMMA, Hydrogen Peroxide
- Demonstrated ability to maximize the biocompatibility of products using industry guidelines and advanced testing technologies.
- Ability to complete complex tasks using creativity, personal experience and good judgment.
- Ability to work cross-functionally with Product Development, Operations and Marketing.
- Demonstrated interpersonal communication skills.
- Be a positive, energetic team player, and an advocate for product excellence and quality.
- Must be results oriented, a quick learner, and able to respond to the urgent needs of the team ensuring all deadlines are met.
To find out more about Real please visit www.realstaffing.com