Quality Assurance Specialist Together, we can change healthcare worldwide. At our client, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
Responsibilities:- Experience in a regulated environment
- Experience working with audit findings, corrections, and corrective actions
- Experience in medical device, pharmaceutical and/or a comparable regulated environment
- Influence management skills; ability to work constructively across all functions of the organization as well as external customers
- Project management skills
- Quality System documentation systems (e.g. Agile) and Audit documentation systems experience (e.g. Trackwise)
- Experience reviewing technical documentation
- Strong written and verbal communication skills
- Ability to educate people in Quality Systems and the Audit program
- Experience with quality tools and process improvement techniques
- Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
- Strong analytical and decision-making skills
Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and our client quality requirements in general and specific to CAPA.
Physical Job Requirements:
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America) Travel 10% domestic and internationally
