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 electrophysiology and heart failure (EPHF), allowing people to restore their health and get on with their lives. 

For years, Abbott’s MEDICAL DEVICES businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine finger sticks. 

The Change Specialist II is responsible for analyzing and processing change requests in the designated PLM system, with a focus on document and part changes, with adherence to SOPs/WIs.  This includes communication with change originators on issues identified and how to correct them.  The Change Specialist II also assigns change implementation tasks, enters information into the ERP system, and releases the change request for use within the organization. The role is also involved in Records Management activities.

WHAT YOU’LL DO

• Assure Effective Change Order Administration Ensure that all change requests comply with procedure requirements. Coordinate and control the processing of all documentation change requests, procedures, and appropriate documentation Coordinate implementation of change requests with all affected areas/facilities.
• Maintain accurate configuration control part numbers and revision level assignments. Maintain product configurations by ensuring accuracy of Bills of Materials. Control Device Master Records. Maintain item master accuracy by updating additions, deletions, and other changes as required
• Assure effective documentation control administration Monitor and prioritize routine documentation activities and requests to ensure customer expectations are met. Train departmental employees as required. Distribute notifications and updated documents to applicable areas, as required Develop and maintain documentation procedures. Proofread documents for accuracy and adherence to policies, as necessary.
• Provide customer support to Engineering projects Support Engineering projects to ensure accurate product configuration and documentation of new products. Support project teams to ensure change requests are implemented to meet deadlines. Support Custom Device Requests to ensure accurate documentation, as necessary.
• Provide support to records management and archiving activities. Support Customer requests such as; retrieval of old history including down rev. documents and device history, provide copies of procedures and/or procedure books as necessary, update distribution lists etc., perform all records management archiving and retrieval processes.
• Other Duties: Provide support to team activities of the Documentation Services department and any initiatives related to all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

Qualifications:

• AA or BA/BS Degree or Equivalent
• 2-4 years of experience in a Document/Engineering Change Control role, preferably in a regulated industry
• Intermediate Microsoft Office skills
• Ability to enter data and information into multiple business systems (PLM, ERP)
• Intermediate knowledge of systems  (PLM, ERP)
• Must have strong interpersonal  skills
• Able to contribute to a  department or cross-functional problem-solving team
• Ability to work in a geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Strong verbal and written communications with ability to effectively communicate with change originators and other Documentation Services staff 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 maintain regular and predictable attendance.
• Regularly scheduled overtime is a requirement of this position.

WHAT WE OFFER  

At Abbott, you can have a good job that can grow into a great career. We offer: 

·        A fast-paced work environment where your safety is our priority

·        Production areas that are clean, well-lit and temperature-controlled

·        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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