Quality Systems Analyst

Job description

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 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Job Summary:

Quality Systems Analyst shall assure that complaint handling processes and procedures are complaint with Quality System Regulations and internal IT systems. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by meeting regulatory standards, streamlining processes, and fulfilling business needs.

Job Duties:

Primary duties include:

• Internal liaison and subject matter expert on developing and maintaining complaint handling procedures, forms, and systems. Topics shall include, but are not limited to, the following:
  • Complaint Handling Process
  • Complaint Product Investigation
  • Complaint Product Trending
  • Risk Management
• Coordinates with stakeholders to acquire requirements and coordinate implementation of complaint handling system changes. Actions shall include, but are not limited to, the following:
  • Requirements Drafting
  • User Acceptance Testing
  • System Procedure Updates
  • Implementation Training
• Partner with cross-functional quality teams and business unit Teams to define process improvements and execute process changes.
• Execute training associated with implemented processes to cross-divisional teams
• Aligns regulatory changes with existing business process to ensure compliance
• Support internal and external audits by preparing and providing relevant analysis, when applicable.

Other duties may include:

• Lead and/or participate in Corrective and Preventive Action (CAPA) Investigations, including documentation, implementation of actions and provision of status updates to management, electronically and in meetings.
• 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.

Required Qualifications:

• Bachelor’s degree in a technical field
• 3+ years’ experience in a medical device company.

Preferred Qualifications:

• 3+ years’ experience in a complaint handling or postmarket surveillance role at a Medical Device company

Required Skills:

• Strong Microsoft Office capabilities (Word, Excel, PowerPoint)
• Ability to work in a geographically diverse business environment.
• Ability to leverage and/or engage others to accomplish projects.
• 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 at multiple levels in the organization.
• Strong structured problem-solving skills
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel up to 10%, including internationally.

Preferred Skills:

• Experience with EPIQ Complaint Handling system or equivalent complaint handling system
• Experience working with Windchill PLM or equivalent document management system
• Experience working in a broader enterprise/cross-division business unit model
• Previous experience with executing a project related to the following topics:
• Complaint Handling Process and/or Training
• Regulatory Reporting Timeliness
• EU MDR Implementation
• National & International Postmarket Surveillance regulations

JOB FAMILY:

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