Principal QA (Quality Assurance) Engineer

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 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Position Overview:

Critical thinker with extensive knowledge and experience in Medical Devices regulated environment who:

• Is highly effective communicator who can transform data findings into recommendations to compose reports and executive level presentations.
• Promotes teamwork and cooperation in an organization with a diverse workforce.
• Facilitates and coaches NC & CAPA teams in the application of problem-solving techniques and promote its use and development.
• Naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
• Takes ownership of his/her work and need no prompting to drive productivity, change, and outcomes.
• Builds and leverages cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.

Responsibilities:

• Collaborates with SMEs to determine strategy for communications - so all stakeholders have the right information, clear and actionable problem statement; Investigation tools; Investigation action plan and timing; Root cause; Solution selection; CAPA action plan and effectiveness checks.
• Utilizes the proper and approved investigation tools necessary to drive the team to root cause.
• Able to conduct organized investigations with a well-defined scope, strategy, and timeline documenting status and progress of the investigation and CAPAs.
• Seeks and leverages the skills and technical expertise of internal and external resources to improve the speed and rigor of investigations.
• Ensures users provide the necessary rigor to the CAPA system content including maintaining a live document with all relevant evidence attached, in a timely manner.
• Authors reports that document investigation of issues including definition, scope, product impact, root cause, and corrective actions to prevent the recurrence of the issue.
• Manages & monitor site NC/CAPA/KPIs including reporting requirements, provide detailed updates and information in support of quality & business review forums, also liaising with other Abbott sites to ensure compliance to global requirements & metrics are achieved.
• Leads & executes the NC/CAPA Review board forums. Lead multi-site forums and participate in global forums.
• Leads/coordinates preparation, participates and follows up to Abbott Internal, Corporate and third-party compliance audits.
• Identifies continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for improvement and optimization of business processes / results.

Requirements

• Bachelor's Degree in engineering, Chemistry.
• Requires eight (8) years of medical device quality experience with oversight provided to Manufacturing Operations, and other cGMP areas.
• Advanced knowledge of relevant regulations is required to act as a resource for colleagues.
• Must be able to take accountability with excellent follow up and follow through; owns issues through the full cycle investigation process.
• Experience leading people and/or projects with history of achieving results and outstanding outcomes.
• Must be legally authorized to work in the United States without restriction.
• Excellent written, verbal, and presentation skills and able to work in a fast-paced and changing environment.
• Must be proficient with Microsoft Office Suite and have a working knowledge of computer systems such as TrackWise, SAP, Lotus Notes.

Preferred/Ideal Experience, Education, etc.

• Bachelor's Degree in any: Mechanical Engineering, Software Engineering, Chemical Engineering, Chemistry, or similar.
• 8 years (+) experience in Quality Assurance/Quality Engineering from medical device or pharmaceutical industry.
• Regulations experience in any: 820, FDA, 13485, 14971, MDSAP
• People Leadership experience, e.g. project management or staff management
• Excel experience (e.g. pivot tables, report generation)
• PowerPoint presentations experience

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