Quality Engineer II, Operations

JOB DESCRIPTION

Provide Quality Engineering support for Manufacturing Engineering, Production Sustaining

This is a collaborative position working closely with Operations, R&D, and other functions to ensure a constant state of control and compliance with AVI’s QMS, and FDA QSR requirements.

DUTIES & RESPONSIBILITIES

Under general supervision, ensure implementation of the quality system including:

• Provide Design Assurance Engineering and technical quality support to project teams in the Product Development Process or in support of post market changes

• Work closely with others to recognize opportunities for improvement and drive change through the use of Quality systems.
• Ensures all specifications are met and that applicable requirements are completed and acceptable.
• Support verification and validation activities including the development of protocols/reports, test method validations, biocompatibility, sterilization, shelf life, stability testing, and sample size determination.
• Lead risk management activities including the creation of hazard analysis, FMEA, and other risk management documents.

As a member of the quality team assist or lead the development and implementation of the following quality functions

• Develop and maintain strong working relationships across Access Vascular and suppliers.
• Serve as a core team or extended team member on new product development projects or change control teams. 
  • Prioritize and plan work activities, adapt to changing conditions.
  • Complete risk analysis studies of new designs and processes.
  • Investigate and analyze relevant variables potentially affecting product and processes.
  • Support, maintain, and improve Calibration system.
  • Support incoming inspection of raw materials and components, acceptance controls, disposition of non-conforming materials and investigations.
  • Equipment qualification and preventive maintenance
  • Ensure Supplier conformance to regulatory requirements.
  • Assist manufacturing with production and process control deliverables
  • Support test method validations and Gauge R&R activities.
  • Conduct internal audits
  • Participate in investigations and CAPA’s
  • Participate in third party audits/inspections
  • Support management reviews

  Other activities as deemed necessary

QUALIFICATIONS

• Bachelors' Degree in Engineering or related discipline.
• 3-5 experience in the medical device industry; experience with statistics preferred.
• Experience in writing protocols, and evaluating the results of product and process verification and validation testing
• Working understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.
• Excellent written and verbal communication 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.