What are the responsibilities and job description for the Quality Engineer II, Operations position at Access Vascular Inc?
JOB DESCRIPTION
Provide Quality Engineering support for Manufacturing Engineering, Production Sustaining
This is a collaborative position working closely with Operations, R&D, and other functions to ensure a constant state of control and compliance with AVI's QMS, and FDA QSR requirements.
DUTIES & RESPONSIBILITIES
Under general supervision, ensure implementation of the quality system including :
- Provide Design Assurance Engineering and technical quality support to project teams in the Product Development Process or in support of post market changes
- 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.
- Support verification and validation activities including the development of protocols / reports, test method validations, biocompatibility, sterilization, shelf life, stability testing, and sample size determination.
- Lead risk management activities including the creation of hazard analysis, FMEA, and other risk management documents.
As a member of the quality team assist or lead the development and implementation of the following quality functions
Prioritize and plan work activities, adapt to changing conditions.
Other activities as deemed necessary
QUALIFICATIONS
Physical Demands :
The physical activities described within the job posting are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Access Vascular, Inc is a proud Equal Opportunity / Affirmative Action Employer . All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status or disability status.
About Access Vascular
Access Vascular was founded in 2015 to address the most common and costly complications of intravenous therapy : infection, thrombosis and phlebitis. The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and have demonstrated 6X fewer complications. .
