Principal Quality Engineer Global Post Market Surveillance

always looking towards the future, anticipating changes in medical science and technology.

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 role is based out of our Lake Forest, IL office within ARDx. This position is in the office on site.

What You’ll Work On

The Principal Quality Engineer Global Post-Market Surveillance is responsible for leading, supporting and guiding the Business Units in ensuring Helix enterprise meets all business requirements including regulatory requirements on post market surveillance.

If hired, you will take the lead in setting direction within the organization with respect to the delivery and maintenance of solutions in the complaint handling and post market surveillance space, primarily the Helix Complaint Handling application. You will also ensure that the Helix application aligns to business objectives and provide continuous value to the organization.

In addition:

• Business Lead who coordinates the efforts of a geographically dispersed team of Quality, IT and Data Analysis professionals that constitute the Shared Services Post Market Surveillance team.

• Ensures compliance to ISO 13485, 21CFR 820 Quality System Regulations, and other applicable regulations and standards by providing support for interpretation of regulations, performing gap analysis, and leading activities to implement improvements.

• Possesses and applies comprehensive knowledge of Quality, and its application to the field of Post Market Surveillance.

• Maintains an advanced and up to date knowledge of ARDx global operations and structures in order to enable informed decisions and to provide direction to BU Quality and Regulatory teams and other functional areas.

• Responsibility for delivery of projects on behalf of the Abbott Rapid business and with the cooperation and alignment of the Business Units

• Identifies key barriers/core problems and applies problem-solving skills in order to deal creatively with complex situations. Troubleshoots and resolves complex problems with effective solutions.

• Identify business needs and recommend viable solutions to meet those needs while ensuring regulatory compliance and leading strategic decision making.

• Conduct regular reviews with Business Unit Stakeholders to correctly prioritize requests for inclusion in future releases.

• Partner with IT in delivering solutions on time and on budget.

• Analyse the results of solution implementation to determine effectiveness and capture lessons learned.

• Makes decisions under conditions of uncertainty, sometimes with incomplete information, that produce effective outcomes.  Utilizes risk assessment techniques in such circumstances. 

• Effectively delegates work to direct reports and manages through to successful completion.

• Analyzes quality audit findings and recommends modifications in products or standards. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvements.

• Drives business improvements through mentoring and support for the continuous improvement initiatives.

• Escalation point for quality related non-conformances and CAPAs.

• Drives compliance cross functionally in alignment with the Business Units for collaboration and multi-site adherence to relevant regulatory requirements.

• Investigates, and resolves quality system nonconformance’s (defined during internal and/or external audits.

• Support the development of direct reports through ongoing mentoring and coaching.

Required Qualifications

• Bachelor's degree in similar field

• Minimum 5 years of experience in medical device industry in progressively responsible positions, including at least five years in a leadership role.

• Experience working with electronic complaint management systems

• At least 5 years of experience using MS Word, Excel, Power Point, and management of spreadsheets.

• Able to travel internationally (at least 15% annually).

• Experience working with cross functional teams with various time zones.

• At least 5 years of experience and working knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g. ISO9001/ ISO13485/ ISO14971/ cGMP / CE/ FDA/ PAL/IVDR/MDSAP)

Preferred

• Experience supporting in-vitro diagnostics products

• Experience managing a global complaint handling functional group for medical device or in-vitro diagnostics

• Broad knowledge of engineering and technical applications applied in development of medical devices useful.

Competencies

• Excellent verbal and written communication skills, able to convey appropriate information with clarity and effectiveness. Communicate confidently and effectively with all levels of management, peers and key stakeholders, including timely escalation of quality issues.

• Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.

• Experience working in a broader enterprise/cross-division business unit model preferred.

• 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.

• Excellent computer skills including all MS Office applications

* 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.

The base pay for this position is $80,700.00 – $161,300.00. In specific locations, the pay range may vary from the range posted.

• business
• regulatory compliance
• post market surveillance
• global operations
• quality management systems
• continuous improvement
• complaint management
• electronic complaint management systems
• solution implementation
• medical science
• 21cfr
• risk assessment
• decision making
• shared services
• capas
• verbal and written communication
• surveillance
• regulatory requirements
• quality audit
• problem-solving
• gap analysis
• delivering results