Facilities Engineer

Abbott • San Diego, CA

3d • $81,500 - $141,300 • Onsite

About The Position

The position of Facilities Quality Engineer is within our Cardiometabolic Business Unit in San Diego, CA. This role will support site QA activities and primarily focus on one or more key quality subsystems, including document control, training, complaints, nonconformances, CAPA and/or supplier control.

Requirements

• BS/BA degree in chemistry, biology, or other scientific discipline or equivalent combination of education and work experience
• 1-3 years’ experience in Quality Assurance or Regulatory Compliance experience in a manufacturing environment, preferably in vitro diagnostics
• Writing and Communication Skills (e.g. write technical reports, present data analysis)
• Experience with MS Office including excel and power point
• Must be detail-orientated, self-motivated and available for flexible scheduling

Nice To Haves

• Experience with electronic document control systems highly preferred
• Knowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR
• Demonstrated initiative and problem-solving skills
• Ability or aptitude to use various types of databases and other computer software
• Strong organizational skills
• Ability to clearly, concisely and accurately convey communications
• Knowledge of quality management techniques and application
• Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor

Responsibilities

• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Participate in Quality System processes which may include training, corrective action and preventive action (CAPA) activities, change control, document control and general QMS administrative support.
• Aid in implementing process improvements with respect to Quality Assurance processes.
• Maintain Quality metrics as required.
• Provide support to QA activities for regulatory compliance (i.e. Management Review support, regulatory audits).
• Assist in determining quality attributes and requirements.
• May provide technical assistance.
• Utilize quality management techniques to perform investigations and facilitate solutions.
• Work with managers to coordinate training requirements for employees as required.
• Manage training program and organizational chart as needed.
• Review/approve supplier surveys and make recommendations as required.
• Assist with internal audits and agency audits.
• Manage Document Control as required.
• Drives functional performance to ensure that cross-functional standards and expectations are met.
• Responsible for completing documentation in a timely manner and in accordance with business standards.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.
• Carries out duties in compliance with established business policies.
• Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, laboratory standards and other applicable regulatory agencies.
• Perform other duties and projects as assigned.

Benefits

• Free medical coverage for employees via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement
• the Freedom 2 Save student debt program
• FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level