Quality Engineer

JOB DESCRIPTION:

About Abbott:

Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Position Summary:
The Quality Engineer is a key contributor to the Divisional Post Market Quality team which supports and guides the Business Units in discharging their regulatory obligations to conduct Post Market Surveillance activities.

Key Responsibilities:

• 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.

• Perform other duties and projects as assigned.

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

• Obtains detailed knowledge of ARDxs global operations and structures to enable informed decisions and to providing direction to BU Quality and Regulatory teams and other functional areas.

• Responsibility for delivery of projects on behalf of the Division and with the support 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.

• Seeks consensus for decisions under conditions of uncertainty, sometimes with incomplete information, in order to produce effective end results. Applies risk assessment techniques in such circumstances.

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

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

Education, Experience and Requirements:

• Fluent business English speaker with good interpersonal, excellent communication and presentation skills
• Excellent interpersonal, written and verbal communication skills, including ability to make clear, well founded decisions regarding conformity during audits.
• Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
• Proficient with MS Word, Excel, Power Point, and management of spreadsheets.
• Third level qualification.
• Minimum 3 years of experience in medical device industry including;
• Experience with Post market Surveillance, both active and passive, including the generation of periodic reports.
• Competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ cGMP),
• Awareness of relevant laws and regulations (e.g. CE/ FDA/ PAL/IVDR/MDSAP)
• Broad knowledge of engineering and technical applications applied in development of medical devices useful.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

ID Infectious Disease

LOCATION:

Ireland > Galway : Parkmore East Business Park

ADDITIONAL LOCATIONS:

WORK SHIFT:

Ie - 37.5Hst0 (Ireland)

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Not Applicable