QA/ QC Engineer
Ashland, VA US
A leading medical device company is seeking a Quality Assurance / Quality Control Engineer to assist with product release activities, process controls and facility compliance.
Primary responsibilities will include:
- Customer Acceptance (CA) testing and Commissioning of finished medical devices and analytical instruments manufactured and repaired onsite.
- Generating and organizing Device History Records (DHRs), along with other testing/product release paperwork.
- Incoming inspection, acceptance/rejection of parts and components used for production.
- Communicating with vendors to obtain compliance files as necessary.
- Coordinate/manage calibrations and preventative maintenance of controlled equipment.
- Undertake regular facility control checks to ensure Good Manufacturing Practice (GMP).
- Perform basic data reporting/analysis and trending on product and process performance.
- Participate in audits and inspections with the Notified Bodies and Regulatory authorities for ISO and QSR compliance, acting as the sites SME for QA/QC.
- Input into ITL's Quality Management System (QMS) and site specific Standard Operating Procedures (SOPs).
- Implementation of ITL's QMS SOPs for Design and Development into the Virginia Site.
- Must possess at a minimum, a Bachelor's Degree in an Engineering, Manufacturing or Repair Technologies field of study, or similar technical discipline, as well as 3 to 5 years industry experience working in a QA/QC role within a manufacturing type environment.
- Experience working and implementing compliant SOPs to ISO 13485, ISO 9001 and 21 CFR Part 820 is a must.
- A capacity to work with basic engineering drawings, manufacturing and test procedures, along with inspection, measuring and test equipment, is required.
- Direct experience working with Medical Devices or electromechanical instrumentation is required.
- The Ability to work independently, with a strong commitment to customer satisfaction.
- Experience with Medical Device Risk Management (ISO 14971) is a plus.
For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.
Richmar is an Equal Opportunity Employer.