Quality Manager, Enterprise Systems

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the

• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

• Carries out duties in compliance with established business policies and procedures.
• Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Responsibility to understand and maintain awareness of the Quality consequences which may occur from the improper performance of their specific job.
• Managing, directing and supporting the ID Enterprise Systems QA team. Effectively delegates work to direct reports and manages through to successful completion.
• Ensuring the coordination and delivery of Quality and systems improvement initiatives within ID.
• Planning, directing, and managing cross-Business Unit and cross-functional Quality and systems programs, ensuring successful outcomes in line with business strategy.
• Authoring and maintaining ID Quality Processes and Procedures to ensure compliance with Abbott Corporate Policies, external Quality standards/regulations, and customer (Business Unit) requirements, as needed.
• Supporting and directing ID sites in their alignment to ID Quality processes and procedures.
• Designing and delivering training of Quality system processes and enterprise systems, as required.
• Managing and supporting the Quality aspects of the RMDx and ID enterprise system maintenance and improvements, including: accelerating implementation of system improvements in alignment with business strategy, ensuring that all system changes are appropriately assessed and tested prior to implementation, and promoting Quality behaviors across functions throughout project activities.
• Develop and support a strong enterprise systems business community, engaging with SMEs and stakeholders across BUs and their sites to ensure enterprise systems meet business needs and business feedback feeds system continuous improvement activities.
• Providing Quality support and direction to sites and shared service functions during implementation of Quality and e-system improvements.
• Performing detailed Quality review and approval of Quality documents, such as process documentation, SOPs, Change Orders, and Quality records to check for accuracy, completeness, and traceability, both for new documents and for revisions.
• Coordination, execution, monitoring, and maintenance of Quality processes where designated as Process Owner/Subject Matter Expert, working across Divisions within Abbott to ensure ID processes are aligned with current best practice. Managing and supporting Process Owners/Subject Matter Experts to maintain and implement process improvements for applicable processes.
• Identifying and implementing opportunities for continuous improvement within the ID Quality System processes.
• Reporting of Quality metrics and KPIs to applicable Quality leadership and within the quarterly Division Management Review, as needed.
• Act as the key Quality liaison to ID sites.
• Participating as required in any Customer or Certification audit and other such inspections.
• Support other QMS or program activities as required.

• A third-level qualification in a related field, along with 7–10 years of experience in a regulated manufacturing environment, is required.
• Demonstrated proficiency in recognized Quality Management Systems and comprehensive knowledge of global medical device regulations. (e.g. ISO9001/ISO13485 / ISO14971 / 21CFR820 QSR, / MDR/ IVDR /MSDSAP /cGMP etc.)
• Experience of working across cross-functional and global teams delivering large-scale and/or global programs.
• Advanced experience implementing electronic QMS software applications.

• Certified Project Management Professional (PMP).
• Certified Lead Auditor.
• Certified ISO 13485 and/or ISO 9001 Internal Auditor.
• Strong technology awareness in line with technologies in use across RMDx (e.g. MS Project, MS Office, MS Visio, SharePoint).

• Ability to effectively direct and/or lead large-scale and global programs, ensuring business value is delivered and milestones are met, including the management of requirements gathering and refinement, appropriate engagement in IT Delivery project activities, and organizational change management execution.
• Ability to apply risk management principles and astute data analysis to influence decision making at the leadership and functional level.
• Ability to lead cross-functional business conversations and negotiate effectively with stakeholders to ensure optimal and compliant outcomes.
• Effective impact assessment of QMS and enterprise system changes, ensuring all are appropriately assessed and communicated.
• Experience in handling and delivering multiple projects simultaneously with successful outcomes that bring value to the organization.
• Delivering Quality projects in a complex and multi stakeholder environment
• Experience in working with and leading cross-functional teams such as Quality, Regulatory, Purchasing, Supply chain, Marketing, etc.
• Ability to anticipate and circumnavigate roadblocks that could impede project progress and/or compliance.
• Team leadership experience, with direct management, mentoring, and coaching of junior resources and cross functional teams.
• International exposure and experience, operating across multiple time zones.
• Experience of working and communicating effectively with GMP-compliant sites, service delivery sites, commercial affiliates, and laboratories.
• Handles complexity and changing circumstances and be able to communicate effectively with wide audiences ranging from site-level personnel to senior leadership.
• Receptive to working in a fast-paced, constantly changing work environment that genuinely looks for those capable of stepping out of their comfort zone on a day-to-day basis.
• Work collaboratively and respectfully with others and be aware of cultural differences at the global level.
• Ability to role model compliance behaviors in all situations.
• Work with appropriate parties to manage and resolve Quality System and enterprise system issues, working collaboratively to create, embed and sustain compliance-focused outcomes across ID business unit and sites.
• Fluent business English speaker with excellent interpersonal, communication, and presentation skills.

• Experience of leading large-scale change initiatives and active stakeholder management across multiple functions.
• Ability to work respectfully with culturally diverse groups of people, able to communicate effectively at all levels of the business, and with both technical and non-technical people, adapting approach to suit the audience.
• Experience managing QA enterprise systems for medical device or in-vitro diagnostics
• Broad knowledge of engineering and technical applications applied in the development of medical devices.

Abbott