Facilities Engineer
Thornton Tomasetti
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Benefits offered by this job
Job summary
Abbott in San Diego, CA seeks a Facilities Quality Engineer to implement and maintain the Quality System and support CAPA, change control, and document control activities. You will help drive process improvements, maintain quality metrics and assist with regulatory compliance activities.
The role requires a BS/BA in a scientific field and 1–3 years of QA/regulatory experience in manufacturing, with strong writing skills and proficiency in MS Office. On-site work with standard shift.
Qualifications
- Bachelor's degree in chemistry, biology or related science field
- 1–3 years’ experience in Quality Assurance or regulatory compliance in manufacturing
- Strong writing and data-analysis capabilities
- Proficient with MS Office including Excel and PowerPoint
- Detail-oriented, self-motivated and able to handle flexible scheduling
Responsibilities
- Implement and maintain the effectiveness of the Quality System.
- Support CAPA, change control, document control and general QMS admin tasks.
- Assist process improvements for QA; maintain quality metrics.
- Support regulatory audits and management reviews.
- Coordinate training requirements and manage documentation as needed.
Skills
Education
Tools
Job description
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, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.
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.
- 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 position of Facilities Quality Engineer is within our Cardiometabolic Business Unit in San Diego, CA.
- 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.
- 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
- 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
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.
DIVISION: CMI ARDx Cardiometabolic and Informatics
Standard
No
Not Applicable
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Work in noisy environment
Abbott is an Equal Opportunity Employer, committed to employee diversity.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.
an equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
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