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 114,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
Quality Assurance Engineer
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
The Quality Assurance Engineer position is within our CMI Unit located in Pomona, California. This role plays a critical part in ensuring product and process quality, compliance, and continuous improvement across operations.
Key Responsibilities:
- Lead quality engineering activities related to:
- Product and process changes
- Product/process quality issues
- Compliance concerns
- Partner with operations to drive process improvement and continuous improvement initiatives.
- Conduct process audits within operational areas to ensure adherence to quality standards.
- Support the development of new products, including participation in design control activities.
WHAT YOU’LL DO
- Actively partner with operations to perform process audits to identify and implement improvement initiatives as required.
- Identify, review, and implement effective process control systems to support the development, qualification, and/or on-going manufacturing of products to meet or exceed internal and external requirements.
- Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations.
- Perform Risk Assessments, as required, across functions, including FMEA, change management, and issue investigation / resolution.
- Lead in the review and/or implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
- Assist in the review, development, and execution of streamlined business systems which effectively identify and resolve quality issues.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Perform root cause analysis of product quality issues. Apply appropriate tools (e.g. statistics, fault tree analysis, etc.). Work with peers to develop corrective actions.
- Perform failure mode analysis on new or existing products. Ensure all reasonable failure modes are identified. Working with peers, develop mitigations for failure modes, and verify the effectiveness of these mitigations.
- Work on problems of limited scope.
- Lead the investigation, resolution and prevention of product and process non-conformances.
- Lead process control and monitoring of CTQ parameters and specifications as required.
- Appropriately document experiment plans and results, including protocol and report writing/reviews.
- Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
- Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
- Coordinates for both new products/processes and changes to existing products/processes develop verification and validation plans that assess if requirements are met.
- 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. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
- Carries out duties in compliance with established business policies.
- Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
- Perform other duties and projects as assigned.
Required Qualifications
- BS/BA degree in Engineering or Technical Field.
- Five years of experience; preferably engineering experience and demonstrated use of Quality Tools-methodologies.
- Solid communication and interpersonal skills.
- Strong computer skills including MS office.
- Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
- Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor.
- Must be detail-orientated, self-motivated and available for flexible scheduling.
Preferred Qualifications
- An engineering or science background in FDA regulated industry.
- Experience with root cause analysis, failure mode analysis, verification, and validation.
- Statistical tools including basic statistical inference, graphical methods, regression.
- Experience with process validations, design verification and design validation studies.
- Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnostic.
- Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
- Advanced skills including statistical/data analysis and report writing skills.
- Prior medical device experience preferred.
- Knowledge of Quality System Regulations.
COMPETENCIES:
- Analytical Skills (e.g. statistical, risk analysis, engineering analysis)
- Writing and Communication Skills (e.g. write technical reports, present data analysis)
- Interpersonal Skills
- Drives for results
- High level of attention to detail
- Problem solving
- Adaptability
Apply Now
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.
JOB FAMILY:
Operations Quality
DIVISION:
TOX ARDx Toxicology
LOCATION:
United States > Pomona : 829 Towne Center Drive
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Work in a clean room environment, Work in noisy environmentAbbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
