Senior Quality Assurance Associate

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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 109,000 colleagues serve people in more than 160 countries.

We have an exciting opportunity for a Senior Quality Engineer within our Abbott Rapid Diagnostics business located at Portsmouth, VA. In this role, you will be responsible for quality engineering activities that address quality system implementation and alignment, product/process change management, CAPA program effectiveness, risk management, and supporting facility and laboratory teams in quality compliance of applicable validations and qualifications. You'll partner with operations for process improvement and continuous improvement initiatives.

RESPONSIBILITIES

• Leading and/or contributing to quality system alignment, product/service, metrics, and process improvement projects.
• Act as quality assurance subject matter expert for support of validation and qualification activities that may impact material or laboratory controls, facilitating the application of validation/change controls, risk management, quality planning and implementation of validation or qualification plans.
• Works closely with facilities, commercial, supply chain, information technology, operations, and sister site SMEs to prevent non-conformities and provide solutions to complex issues.
• Support multiple projects, balancing priorities and resources to meet project and management expectations.
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations
• Perform root cause analysis of quality issues. Apply appropriate tools (e.g. statistics, fault tree analysis, etc.). Work with peers to develop corrective actions
• Supports development and review of validation and qualification plans and test scripts. May support projects in multiple quality systems.
• Support the QI and CAPA processes by performing investigations and root cause analysis and determining action plans and driving the actions to closure.
• 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

BASIC QUALIFICATIONS

• BS/BA degree in field of science such as Chemistry, Microbiology, Biology, Biochemistry or Engineering or equivalent in related field or equivalent experience
• Minimum of 5 years' experience in a quality role within the biotechnology industry with 3-5 years of progressively responsible positions
• Minimum of 3 years of CAPA system, non-conformity system and quality system process improvement experience.
• Minimum of 3 years hands-on risk management experience in maintaining risk management files such as UMFMEA/DFMEA/PFMEA, plans, reports, etc.
• Minimum of 3 years of manufacturing/quality engineering experience (design controls/change control, process validation, on market engineering support and risk management) in a regulated environment.
• Experience with root cause analysis, failure mode analysis, verification, and validation
• Experience reviewing and approving process or test method validations, equipment qualifications, validations, etc. is required.

PREFERRED QUALIFICATIONS

• Previous supervisory experience in a manufacturing QA role in the IVD industry and/or DOA (Drugs of Abuse) industry is highly desirable
• Process, QMS or Supplier auditing experience desired.
• Experience with reagent or ELISA manufacturing, or laboratory testing using LC-MS/MS, GC-MS/MS or other analytical methods desired.
• Lean Six Sigma (Black or Green Belt), Certified Quality Engineer, Certified Quality Auditor, etc. desired.
• Knowledge of FDA QSRs, ISO 13485:2016, ISO 14971 standards and GMP, GLP and GDP requirements.
• Knowledge of computers and software programs including Word, Excel, Access, Visio, Minitab/statistical packages, PowerPoint and quality management software (Trackwise, Agile, Master Control, etc.).
• Statistical tools including basic statistical inference, graphical methods, and regression.
• Experience with process validations, design verification and design validation studies
• Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor.
• Detail-orientated and available for flexible scheduling.

COMPETENCIES

• Analytical Skills (e.g. statistical, risk analysis, engineering analysis)
• Team player
• Interpersonal Skills
• Drives for results
• High level of attention to detail
• Collaboration