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 113,000 colleagues serve people in more than 160 countries.

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. 

WHAT YOU'LL DO

This position is responsible for leading the development of and maintaining quality systems and providing quality system support for the site and/or division (e.g. commercialized products, new product development, manufacturing, and/or system compliance).

Position required to support Quality System Integration (CAPA), coordination of regulatory inspections for Global Strategic Compliance.

Job Duties:

• Provides Quality System Body of Knowledge expertise and support to organization.
• Ensures compliance to ISO 13485 & 21CFR 820 Quality System Regulations by providing support for interpretation of regulations, performing gap analysis and lead activities to implement improvements.
• Monitors external sources of information to identify applicable regulations and standards and determine necessity of company product conformity.
• Leads multi-functional teams in completing program directed or continuous improvement activities.
• Identifies and implements data analysis, systems evaluation, and product assessment to ensure system conformance and ensure finished products meet standards and specifications; implement and drive changes where needed.
• Lead in the implementation of assurances, process controls, and CAPA related systems designed to meet or exceed internal and external requirements.
• Lead in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
• Lead and implement improvement methodologies (e.g. Lean, Six Sigma) and other quality tools to implement process improvements to enhance product quality and reduce process variance by identifying opportunities in quality system compliance, device, and process.
• Analyzes quality audit findings and recommends modifications in products or standards. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvements.
• Monitors compliance of company policies and procedures with external standards and regulations (e.g. compliance with FDA, BSI, EEO regulations, etc.).
• Plan, perform, support and document QMS compliance audits. Track audits to standards and regulations
• Support the setting of the audit schedule, maintenance of the schedule, and/or update it as necessary
• Serve as a CAPA System Subject Matter Expert, identify necessary preventive actions to stay in compliance with external requirements, as well as teaching other CAPA Users at all levels how to conduct assessments.
• Conduct CAPA investigation and able to judge the quality of investigations based on technical knowledge, tracks issues through to closure including reviewing the corrective action taken.
• Support internal and external audits as subject matter expert for sustaining state of the art conformity during the product life cycle.
• Builds strategic internal and external partnerships to further division's compliance program success
• Communicates to Management the compliance status of the business units quality system
• As appropriate, participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality System function as a Team Member)
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities, on occasion, as assigned.

EDUCATION & EXPERIENCE YOU'LL BRING:

• BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred
• 6+ years’ experience
• Previous Quality experience and demonstrated use of Quality tools/methodologies
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
• Solid communication and interpersonal skills
• Lead auditor certification for ISO13485 or 9001 preferred
• Demonstrated and impact project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality system-related issues in a timely and effective manner
• Advanced computer skills, including gap analyses and report writing skills
• Prior medical device experience
• 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 matrix and geographically diverse business environment
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results 
• Ability to work effectively within a team in a fast-paced changing environment
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Multi-tasks, prioritizes and meets deadlines in timely manner.
• Ability to travel approximately 30%, including internationally.
• Statistical tool analysis knowledge preferred
• Microsoft Office Suite proficiency preferred (Word, Excel, Power Point, Visio, Project)

WHAT WE OFFER:

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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