Job Description
We are seeking a highly skilled and experienced Senior Manager, Quality to support our Manufacturing Quality team. This role is critical in ensuring that our products meet the highest standards of quality and compliance. The ideal candidate will have a strong background in quality management within the medical device industry and a proven track record of leading quality initiatives in a manufacturing environment.
Duties & Responsibilities
- Lead and manage the Manufacturing Quality team to ensure compliance with all regulatory requirements and company standards.
- Develop, implement, and maintain quality systems and processes to support manufacturing operations.
- Oversee the investigation and resolution of quality issues, including root cause analysis and corrective/preventive actions.
- Collaborate with cross-functional teams, including R&D, Engineering, and Operations, to ensure quality is integrated into all aspects of product development and manufacturing.
- Conduct regular audits and inspections of manufacturing processes to ensure adherence to quality standards.
- Provide leadership and guidance on quality-related matters to ensure continuous improvement and operational excellence.
- Prepare and present quality reports and metrics to senior management.
- Stay current with industry trends and regulatory changes to ensure compliance and best practices.
- Ensure compliance with clean room standards and protocols, including monitoring and maintaining clean room environments.
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or a related field; advanced degree preferred.
- Minimum of 8-10 years of experience in quality management within the medical device industry.
- Strong knowledge of FDA regulations, ISO standards, and other relevant quality standards.
- Proven experience in leading and managing quality teams in a manufacturing environment.
- Excellent problem-solving skills and the ability to make data-driven decisions.
- Strong communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
- Certification in quality management (e.g., ASQ CQE, CQA) is a plus.
- Experience with clean room environments and maintaining clean room standards.
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.
