Reporting into the Quality Department, this role has responsibility for Quality related actions in support of new product development and commercial manufacturing including the support of Access Vascular’s first commercial product.
Responsibilities include, but are not limited to:
Under general supervision, ensure implementation of the quality system including:
· Work closely with others to recognize opportunities for improvement and drive change through the use of Quality systems.
· Ensures all specifications are met and that applicable requirements are completed and acceptable.
· Participate in the development of protocols/reports in support of test method validations, design and process verifications and validations, biocompatibility, sterilization, shelf life, stability, and risk management including sample size determination
As a member of the quality team assist or lead the development and implementation of the following quality functions
- Develop and maintain strong working relationships across Access Vascular and suppliers.
- Prioritize and plan work activities, adapt to changing conditions.
- Support, maintain, and improve Calibration system.
- Support incoming inspection of raw materials and components, acceptance controls, disposition of non-conforming materials and investigations
- Equipment qualification
- Preventive maintenance: schedule planned and unplanned PM
- Ensure Supplier conformance to regulatory requirements.
- Assist manufacturing with production and process control deliverables
- Support test method validations and Gauge R&R activities.
- Training: maintain the training database and ensure that required training is completed
- Conduct internal audits
- Participate in investigations and CAPA’s
- Participate in third party audits/inspections
- Support management reviews
Other activities as deemed necessary
· Bachelors' Degree in Engineering or related discipline.
· 3-5 experience in the medical device industry; experience with statistics preferred.
· Experience in writing protocols, and evaluating the results of product and process verification and validation testing
· Working understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.
· Excellent written and verbal communication skills