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.

Leading an active lifestyle is important to the many people we serve. In Abbott’s Heart Failure division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in heart failure, allowing people to restore their health.  

Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take actions and accomplish goals. We are seeking a high caliber CAPA Quality Engineer II to join our growing team. This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.

WHAT YOU’LL DO 

• Support all Business Unit initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

• Lead Corrective/Preventive Action activities in supervision of Senior CAPA Engineer or independently.

• Prepares all relevant CAPA metrics per business unit requirements in supervision of senior team member or independently.

• Ensures compliance and timeliness of all business unit CAPAs. Performs other related duties and responsibilities, on occasion, as assigned.

• Communicates confidently and effectively with all levels of management, peers and key stakeholders, including timely escalation of quality issues.

• Participate in, or lead, the completion of CAPA projects, assuring compliance, quality and timeliness of records.

• Collaborate with cross-functional teams using various methodologies (e.g. Six Sigma root cause analysis/problem solving skills).

• Lead meetings and communications for CAPA updates, information, and concerns.

• Assist in the initiation, processing and completion of CAPA records in the electronic system.

• Provide support during audits and inspections.

• Complies with U.S. Food and Drug Administration (FDA) regulations, all other applicable regulatory requirements (including non-US regulations, company policies, operating procedures, processes, and task assignments.

• Responsible for completing documentation in a timely manner and in accordance with business standards.

• Travel up to 10% of the time both domestically and internationally by any means necessary to support organizational goals

• Understand and comply with applicable EHS policies, procedures and guidelines.

• Work may require collaboration with other Abbott business units and/or other Abbott divisions.

• Works under general direction; independently determines and develops approach to solutions; work is reviewed upon completion for adequacy in meeting objectives.

• 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.

EDUCATION AND EXPERIENCE YOU’LL BRING 

• Bachelor’s degree in Engineering or Technical Field or equivalent experience.

• 2-5 years CAPA engineering experience and demonstrated use of Quality tools/methodologies.  Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.

• Prior medical device experience preferred.

• Solid communication and interpersonal skills.

• 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.

• Advanced computer skills, including statistical/data analysis and report writing skills

• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing). ASQ CQE or other certifications preferred.

• Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment.

• Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects.

• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner.

• Strong organizational and follow-up skills, as well as attention to detail.

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 onboarding 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  

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. 

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