Quality Engineer - Medical Devices (Onsite, 8mo)

Abbott; Temecula (CA); On-site; USD 70,000 - 110,000; Full time

Job summary

Abbott in Temecula, California is seeking an Engineer, Quality to initiate medical device quality assurance activities in accordance with FDA QSR, ISO 13485 and other international standards. This 8-month, 100% onsite assignment supports device complaint investigations and failure analysis as required, working 6am–3:30pm in a full-scale QA environment.

Key duties include developing incoming inspection processes, providing in-process QA support, completing final acceptance activities, managing

Qualifications

• QA activities compliant with FDA QSR and ISO 13485.
• Support device complaint investigations and failure analysis.
• Develop incoming inspection processes and document review.
• Lead MRB and manage CAPA programs.
• Coordinate with suppliers and contract manufacturers.

Responsibilities

• Develop incoming inspection processes and document incoming inspection activities.
• Provide in-process QA support to include inspection and document review.
• Complete final acceptance activities.
• Manage the sterilization process, including validations and product sterile loads.
• Track nonconforming material and lead Material Review Board (MRB) efforts.
• Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing.
• Lead complaint investigations on returned product.
• Manage corrective action and quality improvement activities.
• Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc.
• Assist in the performance of quality system internal auditing.
• Support quarterly management review meetings.
• Establish, monitor and evaluate quality system metrics.

Skills

Quality Assurance

Inspection

MRB

Corrective Action

Auditing

Job description

Abbott in Temecula, California is seeking an Engineer, Quality to initiate medical device quality assurance activities in accordance with FDA QSR, ISO 13485 and other international standards. This 8-month, 100% onsite assignment supports device complaint investigations and failure analysis as required, working 6am–3:30pm in a full-scale QA environment.

Key duties include developing incoming inspection processes, providing in-process QA support, completing final acceptance activities, managing