Facilities Engineer

Abbott Laboratories; San Diego (CA); On-site; USD 82,000 - 141,000; Full time

Job summary

Abbott Laboratories in San Diego, CA is seeking a Facilities Quality Engineer to support site QA activities, with a focus on document control, training, complaints, nonconformances, CAPA and supplier control.

You will implement and maintain the Quality System, participate in CAPA processes, audits, and regulatory compliance, and help drive process improvements and training programs. This role requires a BS/BA in science and 1–3 years' Quality Assurance experience.

Qualifications

• BS/BA in chemistry, biology, or related field (or equivalent combination)
• 1–3 years’ experience in Quality Assurance or Regulatory Compliance in a manufacturing environment
• Strong writing and communication skills (e.g. reports, data analysis)
• Experience with MS Office including Excel and PowerPoint
• Detail-oriented, self-motivated, and able to work flexible scheduling

Responsibilities

• Implement and maintain the effectiveness of the Quality System.
• Participate in CAPA, change control, document control, and QMS administrative tasks.
• Assist process improvements related to Quality Assurance processes.
• Maintain Quality metrics and support regulatory audits.
• Assist with supplier surveys and internal/agency audits.

Skills

Quality Assurance experience

Regulatory compliance

Technical writing

Attention to detail

Data analysis

Education

BS/BA in chemistry, biology, or related field

Tools

MS Office (Excel, PowerPoint)

Electronic document control systems

Job description

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• 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 and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The position ofFacilities Quality Engineeris within our Cardiometabolic Business Unit inSan 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.

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.
• 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.

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 power point
• Must be detail-orientated, 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 ability to operate as an individual contributor

Compliance announcement: * Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

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.