EDUCATION, EXPERIENCE, QUALIFICATIONS AND SKILLS:
- Bachelor’s degree in Quality Sciences or a technical field preferred
- 3+ years of experience in quality improvement methodologies and tools preferred
- 2+ years of experience in a regulated industry experience that includes FDA and ISO requirements preferred
- Experience in IFS ERP system is a plus
- Experience in quality planning, including risk-based approaches is a plus
- Communication – displays developed interpersonal skills: leadership, team orientation, ability to communicate at all levels
- Flexibility and Adaptability – make effective decisions and maintain effectiveness under changing circumstances and priorities
- Ability to maintain professionalism under pressure
- Teamwork, communication, positive attitude required to support the manufacturing environment
- Ability to read and analyze technical prints and drawings
- Problem Solving – able to perform root cause analysis and implement effective corrective actions
- Project Management – able to effectively manage and complete multiple projects simultaneously
- Computer Skills – Excellent computer skills including but not limited to Microsoft Office Suite
- Willingness to travel <25% to all Aspen locations
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
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.