Engineer, Quality

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

Title: Engineer, Quality

Location: Temecula, California

Duration: 8 Months

Shifts: 6am - 3:30pm

100% Onsite

Summary:

The purpose of this position is to initiate medical device quality assurance activities. These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards. This position will also support device complaint investigation and failure analysis as required.

Essential Duties and 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.

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.