Job Description    

The QC Technician provides direct quality support to manufacturing and supply chain operations. Responsibilities include inspecting materials received, production records, subassemblies, and finished products.  

Duties & Responsibilities    

Support Manufacturing and  Supply Chain Functions:

• Collaborate closely with manufacturing and supply chain teams to ensure that production outputs meet or exceed quality, quantity, and timeliness requirements and demands. This involves monitoring processes, identifying bottlenecks, and addressing any issues that may impact product quality or delivery schedules.

Implementing Effective Process Control Systems:

• Identify and assist with implementation and maintenance of effective process control systems to support product manufacturing.
• Work closely with production teams to ensure procedures are understood and followed, as well as collaborate to identify and resolve quality issues.
• Oversee proper storage and handling of inventory, both raw materials, work-in-progress (WIP), and finished goods.

Performing Quality Control Inspections:

• Conduct inspections of incoming materials, in-process products, and finished goods to ensure compliance with specifications and regulatory standards.
• Communicate with suppliers as needed.
• Perform quality review of manufacturing lot history records.
• Review and verify labeling materials, maintain the label matrix, and label proofs.
• Initiate Nonconforming material reports as warranted.

Maintaining Detailed Quality Records:

• Document and maintain meticulous quality records including lot history records, inspection records, Nonconforming material reports, Purchase Specifications, Quality Inspection Plans, etc.

Segregating, Labeling, and Controlling Nonconforming Product:

• Maintain a clean and organized work environment in accordance with Good Manufacturing Practices (GMP).
• When nonconforming products are identified, ensure that they are properly labeled and segregated from confirming product.
• Collaborate with relevant reams to address issues (e.g., rework, scrap, or corrective actions).

Qualifications    

• High School Diploma
• 5+ years hands on Medical Device manufacturing experience in a quality-specific capacity.
• Demonstrated competency in using general mechanical inspection tools including calipers, micrometers, pin gages, and other common measurement tools.
• Very high attention to detail and organizational skills with a keen understanding of manufacturing/production documentation (Work Instructions, Process Routers, etc.)
• Solid hands-on Good Documentation Practices (GDP) knowledge and experience.
• Ability to read and interpret drawings, specifications, and processes desirable.
• Excellent written and verbal communication and skills.
• Ability to work independently and as part of a team.

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. .