Facilities Engineer

Abbott; San Diego (CA); On-site; USD 81,500 - 141,300; Full time

Job summary

Abbott is seeking a Facilities Quality Engineer in San Diego, CA. In this role, you will support site QA activities, focusing on Quality System subsystems like document control and training.

The position requires a BS/BA degree in a scientific discipline and 1-3 years of quality assurance experience. Abbott offers a competitive salary ranging from $81,500 to $141,300 based on location.

Qualifications

• 1-3 years’ experience in Quality Assurance or Regulatory Compliance in a manufacturing environment.
• Ability to write technical reports and present data analysis.
• Knowledge of federal regulations like QSR’s, ISO, and ISO 13485.

Responsibilities

• Implement and maintain the effectiveness of the Quality System.
• Participate in Quality System processes including CAPA activities.
• Assist in regulatory compliance QA activities.

Skills

Writing and Communication Skills

Detail-oriented

Problem-solving skills

Organizational skills

Education

BS/BA in chemistry, biology, or other scientific discipline

Tools

MS Office

Electronic document control systems

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio spans diagnostics, medical devices, nutritionals and branded generic medicines, and our 115,000 colleagues serve people in more than 160 countries.

The Opportunity

Position of Facilities Quality Engineer in the Cardiometabolic Business Unit in San Diego, CA. This role supports site QA activities and primarily focuses on key quality subsystems, including document control, training, complaints, nonconformances, CAPA and/or supplier control.

What You’ll Work On

• 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.
• Drive 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 and 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.

Required Qualification

• 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 PowerPoint.
• Must be detail‑oriented, self‑motivated and available for flexible scheduling.

Preferred Qualification

• 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 operate as an individual contributor.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

The base pay for this position is $81,500.00 – $141,300.00. In specific locations, the pay range may vary from the range posted.