Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and 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.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Plymouth, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

What you’ll work on

As the Quality Compliance Engineer II, you’ll assure products, processes, and quality records conform to quality standards and establish compliance with the quality system.  This role will include responsibilities for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient safety and meeting business needs.

Responsibilities:

• Support the CAPA Portfolio for the Electrophysiology (EP) business through effective project and process mentorship with CAPA owners and approvers. 
• Prioritize and communicate timelines of individual CAPA projects to facilitate timely completion per the EP Quality System. 
• Process QA requests, ensuring owners are assigned, and timely responses are provided in alignment with quality goals.
• Proficiently lead meetings and communications for QA system information, concerns, and updates.
• Ensure database and record storage maintenance and integrity for QA systems.
• Support execution of CAPA training.
• Identify and execute continual improvement opportunities within the Abbott CAPA process.
• Drive execution of CAPA data analysis, trending, and reporting.  High proficiency with reporting and publishing weekly, monthly and quarterly metrics.
• Support all Abbott initiatives as identified by senior management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Perform other related duties and responsibilities, on occasion, as assigned.

Qualifications

Required 

• Bachelor level degree in Engineering, Technical Field, or equivalent
• 2-4+ years technical experience
• Previous Quality assurance/engineering experience and demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, and ISO 13485
• Solid communication and interpersonal skills
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
• 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.
• Ability to travel approximately 5%

Preferred 

• Advanced degree in Engineering, Sciences, or related discipline
• Medical Device Experience

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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 and @AbbottGlobal.