Job Description
The Manager, Quality will oversee the Quality Management System (QMS), handle customer complaints, manage return goods, oversee post-market surveillance, coordinate Corrective and Preventive Actions (CAPAs), and lead training initiatives. This role excludes responsibilities related to manufacturing quality and design quality.
Duties & Responsibilities
- Quality Management System (QMS):
- Develop, implement, and maintain the QMS in compliance with regulatory requirements.
- Conduct regular audits and reviews to ensure the effectiveness of the QMS.
- Customer Complaints:
- Manage the process for receiving, investigating, and resolving customer complaints.
- Ensure timely and effective communication with customers regarding complaint status and resolution.
- Return Goods:
- Oversee the return goods process, ensuring compliance with company policies and regulatory requirements.
- Analyze return trends and implement corrective actions to reduce return rates.
- Post-Market Surveillance:
- Monitor product performance in the market and gather feedback from customers.
- Conduct post-market analysis and report findings to relevant stakeholders.
- Corrective and Preventive Actions (CAPAs):
- Lead the CAPA process, including identification, investigation, and implementation of corrective and preventive actions.
- Track and report on the status of CAPAs to ensure timely closure.
- Training:
- Develop and deliver training programs related to quality processes and regulatory requirements.
- Ensure all employees are adequately trained and maintain training records.
- Additional support as needed.
Qualifications
- BS in related technical field, preferably Engineering
- 10+ years of Quality experience in the Life Science or Medical Device Industries
- Minimum of 2 years in a Managerial role.
- Embody the Access Vascular Guiding Principles
- Working knowledge of 21 CFR 820 and ISO 13485
- 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
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.
