Company:   AngioDynamics, Inc.

Location:   Queensbury

Status:   Full Time
Employee

Job Category:   Engineering

Occupations:   Bio-Engineering
General/Other: Engineering
Systems/Process Engineering

Career Level:   Experienced (Non-Manager)

Industry:   Biotechnology/Pharmaceuticals
Manufacturing - Other
Medical Devices and Supplies

Reference Code: 211671

Address: 603 Queensbury Ave.
Queensbury, NY 12804

QUALITY ENGINEER - SUPPLY CHAIN (211671-017)

Description

The Quality Engineer is responsible for assuring product quality through supplier qualification, supplier quality metrics, supplier corrective action, supplier audits, participation in cross-functional product development teams and supervision of incoming/post-sterile inspection functions.

• Evaluate the process controls and quality systems of the suppliers that provide the components for our medical devices through supplier audits and communication with the suppliers
• Facilitate the supplier corrective action (SCAR) program that will follow through on corrections that need to be implemented as a result of failure investigations that point to the supplier
• Build supplier quality relationships as we reduce product cost and improve the quality of our products
  Supervise the Incoming inspection area and post-sterile inspection area
• Provide QE support for existing products and assist with the transfer of new products to production to drive continual improvement
• Monitor and improve the Incoming inspection process and the quality of the inventory raw materials that we receive
• Support product complaint failure investigations
• Participate with the material review board in determining the disposition of nonconforming materials
  Design verification and validation strategy development and review and approval of validation and verification protocols and testing activities
• Assist with the development of Incoming quality control inspections and implementation of appropriate measurement methods and test equipment
• Provide statistical analysis support where appropriate (e.g. SPC, design of experiments, etc)
• The above is not intended to be an all-inclusive list of responsibilities.  Other activities may be assigned as required by management

Ideal Candidate will possess:

• Proven ability to use MS Word, Excel, and databases
• Excellent organizational skills required
• Good verbal and written communication skills required

Ideal Candidate will possess:

• Bachelor's degree in Quality Engineering or related technical field
• Three (3) - five (5) years experience in the FDA-regulated industries, or equivalent combination of education, training, and experience
• Requires in-depth knowledge of FDA cGMP/QSR’s and ISO 13485 standards
• Proven supervision and supplier audit experience
• Statistical Process Control and knowledge of statistical analysis techniques
• Validation/Qualification/Verification protocol development
• Certified Quality Engineer (CQE) is desirable