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](https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and [FreeU](https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 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.
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
