Abbott Senior Quality Engineer in Princeton, New Jersey
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 107,000 colleagues serve people in more than 160 countries
Abbott Point of Care is a global leader in providing critical medical diagnostic and data management products for rapid blood analysis that are intuitive, reliable, and cost-effective. Our i-STAT System is an advanced, portable diagnostic tool that provides real-time, lab-quality results within minutes to accelerate patient-care decision-making. The i-STAT System has the industry’s most comprehensive menu of tests in a single, with-patient platform, including tests for blood gases, electrolytes, chemistries, coagulation, hematology, glucose, and cardiac markers. By delivering lab-quality results in minutes, our i-STAT System fosters a collaborative, patient-centered environment while driving improved operational performance.
Our Princeton, NJ site has an opportunity for a Senior Quality Engineer .
The Senior Quality Engineer will lead, ensure technical consistency, and ensure compliance of APOC’s CAPA Quality System. Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer.
WHAT YOU’LL DO
Serves as the CAPA system (ABTRAQ) site coordinator. Ensure that investigations are thorough, factually written and focused on root cause determination. Ensure that corrective actions are appropriate for the elimination of root cause and prevent re-occurrence. Assist in the development of effectiveness check plans and ensure that all effectiveness checks are appropriate at assessing the effectiveness of closed CAPAs.
Provide guidance/training to all personnel performing activities within the electronic CAPA system (ABTRAQ). Assist in the CAPA system data collection, interpretation and documentation to support all system metrics (monthly, quarterly, and ad hoc report needs) on a timely basis.
Independently lead groups and projects to resolve complex issues. Analyze complex problems and identify their impact. Draw conclusions reflecting broad business needs. Mentor others on best practices and ensure compliance.
Cross-functionally lead Quality System process improvements which may include training, corrective action and preventive action (CAPA) activities, product and process planning, quality audits, validation.
Makes timely and effective decisions related to business issues within scope of responsibility; appropriately elevates high risk issues / decisions; identifies and quantifies risks and their consequences relative to the success of a project / task; recommends appropriate action; decisions or recommendations would typically achieve departmental / project objectives.
Responsible for implementing and maintaining an effective Quality System.
Understand and comply with applicable EHS policies, procedures and guidelines.
EDUCATION AND EXPERIENCE, YOU’LL BRING
Bachelor's degree or equivalent experience required. Preferably in science, engineering or a closely related discipline with comparable and relevant experience.
Minimum of 5+ years of relevant experience, such as Quality, Compliance, Engineering, within a regulated environment, such as medical device, diagnostics or pharmaceutical industries, to develop the competence required to meet the skills and responsibilities of the position.
Knowledge of applicable US and non-US Quality System Requirements and other relevant regulations for medical devices. Previous experience with regulatory body. Knowledge of software regulations and compliance (21 CFR Part 11); - Knowledge of ISO 13485 and ISO 14971.
A bility to travel up to 10%.
Master’s degree preferred.
ASQ Certified Quality Engineer is a plus.
Knowledge of quality management techniques and the application and principles of quality engineering. Understanding of statistics.
Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors.
Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior. Ability to work independently and in groups; ability to work cross-functionally. Demonstrated initiative and problem-solving skills and critical-thinking skills.
Ability to prioritize. Strong organizational and project management skills. Ability or aptitude to lead without direct authority.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
Training and career development , with on-boarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives and retirement plans
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and history of being actively involved in local communities
*Learn more about our benefits that add real value to your life to help you live fully: * www.abbottbenefits.com at http://www.abbottbenefits.com/pages/candidate.aspx
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com at http://www.abbott.com/ , on Facebook at www.facebook.com/Abbott and on Twitter @Abbott News and @AbbottGlobal.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org