Quality Engineer-Medical Device-Concord, Ca

Essential Functions:

• Responsible for developing and improving the corporate Quality System in conformance to FDA and ISO standards appropriate for world-class suppliers to the medical device industry with the following areas of responsibility:

·       Inspection:

• 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.
• Provide technical support for inspection department.
• Audits
• Internal Audits – Schedule and manage internal quality audits.
• Third Party Audits – Participate in external quality audits and surveys from customers and regulatory agencies.
• Complaints/SCARs
• 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.
• Corrective and Preventive Actions
• Ensure Corrective And Preventive Action (CAPA) activities are initiated when required.
• Monitor CAPA activities from initiation, through closure, and verification of effectiveness.
• Training
• 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. 
• Vendor Evaluation and Approval
• Manage Vendor Evaluation/Approval/Review process. Conduct Supplier Audits as required
• Issue and manage Supplier Corrective Action Requests as required.
• Document Change Orders
• 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.
• Be a company champion for quality and compliance.
• 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.
• Work from limited direction as set by the Head of Quality (currently Director of Engineering and Quality).

Salary:$60-65/hr.

Please send resume to kjohnson@nelsonconnects.com