QUALITY AND REGULATORY REQUIREMENTS:
- Knowledge of quality system including the quality manual, quality policy and applicable procedures and work instructions
- Establish, implement, and maintain the quality system in accordance to FDA Quality System Regulation, ISO 13485, European Union Medical Device Directives, and Canadian Medical Device Regulations
EDUCATION, EXPERIENCE, QUALIFICATIONS AND SKILLS:
- Minimum: high school diploma
- Preferred experience with PLM, PDM, ERP systems in an organization that manufactures high volume, complex products
- Project management, self-management, and multi-tasking skills
- At least 1+ year experience in manufacturing, quality systems, and system administration
- Strong computer skills and knowledge of MS applications, Word, Excel, Powerpoint, Access
- Understanding of Electronic Document Management System & Electronic Change Control Systems
- Must have strong verbal and interpersonal communication skills
- Must be detail orientated
- Strong English writing, editing, and grammar skills
- Must have a positive attitude while maintaining flexibility
PHYSICAL REQUIREMENTS:
NOTE: The inability to perform any of the following physical requirements does not preclude an applicant from consideration unless, following an individualized analysis, it is determined that the physical requirement is an essential job function and the applicant is unable to perform such function with or without reasonable accommodation
Please refer to the Essential Duties and Responsibilities.
At Aspen Surgical, we strive to build a diverse work force through equal opportunity employment that embraces and leverages the differences that each individual has to offer. This job description is only a summary of the typical functions of the job and not intended to be an exhaustive list of all job responsibilities, tasks, and duties. Aspen Surgical Products, Inc. is an equal opportunity Employer F/M/Disability/Vet/Sexual Orientation/Gender Identity.
