Act as a study director for industrial sterilization validations of medical devices from study development through completion.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- The responsibilities with respect to the planning of tests and evaluation of results:
- Interface with the laboratory, sterilization personnel, and customers to determine sterilization needs
- Evaluate testing requirements for validation
- Prepare quotations for validation studies
- Write, review, and approve protocols
- Provide direction during the conduct of validation studies
The responsibilities for reporting opinions and interpretations:
- Understand and interpret sterilization standards
- Write, review, and approve final reports
- Evaluate out of specification conditions in the sterilization processes
- Advance skills through trade organization seminars or meetings
- Understand the sterilization process and equipment
- Interface with customer during technical visits and audits as needed
- Write, review, and approve work instructions
- All other tasks as assigned by management
QUALIFICATIONS & REQUIREMENTS:
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
EDUCATION and/or EXPERIENCE:
- Bachelor’s Degree or higher in a science or engineering related field with four to six years of medical device experience and knowledge of sterilization standards and process validation.
- The following training programs, certifications, and qualifications are beneficial: ISO Training/experience, GMP Training, AAMI Industrial Sterilization courses as well as Project Management Training.
- Proficiency with Microsoft Office (Word, Excel, Outlook).
- Must have strong spelling, grammar, technical writing and proofreading skills. Must have the ability to communicate effectively with customers and employees of the organization.
- Ability to perform the calculations used in manipulating routine laboratory data.
OTHER SKILLS and ABILITIES:
- Project management, good organization, time management, reading, writing, proofreading and editing skills. Read, understand, and interpret sterilization standards.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- While performing the duties of this job, the employee is regularly required to stand and walk, use hands to manipulate objects or controls, reach with hands and arms, talk and hear. The employee may regularly be required to climb, balance, stoop, kneel, crouch or crawl. The employee is occasionally required to sit.
- The employee must be able to lift and/or move more than 30 pounds with or without the use of mechanical means. Specific vision abilities required by this job include close, color, and peripheral vision and the ability to adjust focus.
To apply, please contact us at HR@iuvobioscience.com.