The Senior Quality Engineer is responsible for developing, improving and maintaining AVIs Quality Systems, and overseeing aspects of the quality control operations. This position may supervise a team of Quality Control technicians ensuring the delivery of high quality product that meet regulatory requirements and customer expectations.
Duties & Responsibilities
- Develop, improve and maintain Quality Systems, ensuring adherence to FDA Quality Management System Regulation (QMSR) requirements, as well as internal compliance.
- Identify and lead continuous improvement activities to enhance AVIs Quality Systems.
- Lead or participate in project-related quality activities (e.g., product release and change control).
- Provide quality oversight including supporting production and supply chain processes in accordance with applicable regulations, standards, and guidelines.
- Effectively execute the nonconformance report (NCR) process including timely and effective execution of the NCR investigations.
- Lead/support in the monitoring and publishing of quality metrics.
- Analyze quality control data and identify trends to implement preventive measures and apply continuous quality improvement initiatives.
- Work collaboratively with other departments such as Operations and Supply Chain to identify and address root cause(s) of quality issues.
- Supervisory responsibilities as needed ensuring efficient management of work schedules to support manufacturing operations.
- Support internal audits.
- Maintain accurate and complete quality control records.
- Perform other related duties as assigned.
Qualifications
- BS in related technical field, preferably Engineering
- 8+ years of Quality Engineering experience in the Life Science or Medical Device Industries
- Embody the Access Vascular Guiding Principles
- Working knowledge of 21 CFR 820 and ISO 13485 is a must
- Ability to review and write technical documentation
- Self-initiator with strong organization skills
- Teamwork, flexibility and adaptability to change
- Ability to communicate and lead through influence
- Proficient problem-solving skills
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.
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. .
What We Do
Access Vascular was founded to address the most common and costly complications of intravenous therapy: infection, thrombosis, and phlebitis. Taking a foundationally different approach to thrombus reduction, the company manufactures intravenous catheters from a hydrophilic material which retains significant amounts of water. Engineered to mimic the body’s natural chemistry, Access Vascular catheters are designed to evade the foreign body response and complications that come with it. Our cleared products are HydroPICC®and HydroMID®. For more information, please visit www.accessvascularinc.com.
