Quality Audits Engineer in Concord, CA

26 Feb 2025

Vacancy expired!

Quality Engineer in Concord, CA- Contract on C2C/W2

Notes: Medical background, vendor management, Root cause analysis, inspect and Audit, hands on with customers issues, respond back to customer queries, good at documentation, have worked on small components, someone coming from Abbott or Stryker or small medical device company
  • Provide support when needed in-process and final inspection processes.
  • Participate in the resolution of all product rejections and returns, internal and external, call and follow-up on Material Review Board Meetings.
  • Internal Audits - Schedule and manage internal quality audits.
  • Third Party Audits – Participate in external quality audits and surveys from customers and regulatory agencies.
  • Ensure timely response to all customer-inquiries including complaints, customer generated Supplier Corrective Action Requests (SCAR’s), and Pulse Systems issued SCARs.
  • Track and manage the timely resolution of all customer inquires, open SCAR’s.
  • Ensure Corrective And Preventive Action (CAPA) activities are initiated when required.
  • Monitor CAPA activities from initiation, through closure, and verification of effectiveness.
  • Train employees, including management, in quality processes and regulatory requirements.
  • Monitor internal training activities to ensure all employees are trained in accordance with Pulse Systems procedures.
  • Manage Vendor Evaluation/Approval/Review process. Conduct Supplier Audits as required
  • Work with other departments to define, qualify, and implement Document Change Orders.
  • Manage the Document Control process to maintain revision control on all internal controlled documents.
  • Ensure that Document Change Orders are tracked and implemented in a timely manner.
  • Support the execution of production schedules consistent with company goals and objectives. Coordinate support from other staff and production personnel as necessary.
  • Prepare materials for and participate in Quality review meetings with management.
  • Adhere to general safety rules, manufacturing procedures, company policies and procedures and other ISO guidelines.

  • ID: #49355335
  • State: California Concord 94518 Concord USA
  • City: Concord
  • Salary: Depends on Experience
  • Job type: Contract
  • Showed: 2023-02-26
  • Deadline: 2023-04-21
  • Category: Et cetera