Quality Assurance Project Manager

2 days ago

Sligo, Ireland Abbott Laboratories Full time

About Abbott

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.

Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 5,000 people across nine sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.

Abbott Ireland Nutrition Sligo

We understand that proper nutrition is the foundation for living the best life possible. That’s why we develop science-based nutrition products for people of all ages. Our products help babies and children grow, keep bodies strong and active, and support the unique nutrition needs of people with chronic illnesses — to make every stage of life a healthy one.

Abbott is a leader in providing enteral nutrition feeding devices, including enteral feeding pumps and pump sets. Enteral feeding (also known as tube feeding) is a means of providing nutrition to people who cannot obtain nutrition by swallowing. Enteral nutrition contains all the calories and vitamins a person needs.

The role of Quality Assurance Project Manager will involve the following:

Role Purpose

Quality Assurance Project Manager operates within the Quality Assurance organization, focusing on feedback and service activities that support and guide the business in fulfilling regulatory obligations related to Enteral Feeding Pumps and accessories. This role provides crucial support to TPs and affiliates, ensuring compliance with Abbott quality policies, procedures, and international regulatory requirements. Quality Assurance Project Manager oversees the TP's within the Sligo AN Device Portfolio, addressing customer feedback, auditing systems, determining quality metrics, and reporting malfunctions.

Major Responsibilities

As a leader of a small team, the Quality Assurance Project Manager will:

- Provide Quality Assurance support to Abbott Nutrition Device TPs, Affiliates, and stakeholders, ensuring compliance with corporate and regulatory timelines.
- Identify and highlight quality issues related to design, manufacturing, and safety programs for AN TP products.
- Support the complaints team by ensuring timely investigation and compliance with procedures for AN Device complaint and CAPA management systems.
- Proactively address customer feedback and repair data to identify and mitigate potential issues.
- Coordinate and ensure timely review and approval of Quality agreements for TPs.
- Oversee Service Centre training requirements.
- Manage the CAPA process for Abbott Nutrition Device TPs.
- Coordinate the Service Centre Process and Key Performance Indicators.
- Schedule and coordinate audit programs for Enteral Pump Service Centres.
- Ensure all documentation complies with AN Device, Abbott Division requirements, MDR/MDD, and ISO regulations.
- Lead and mentor a small team, conducting periodic goal reviews, annual performance evaluations, and career development reviews.

Supervisory/Management Responsibilities

- Manage a small team to ensure the fulfillment of major responsibilities.
- Interact with various levels within the business, including Department Managers, TPs, Service Centre personnel, and other staff functions within Abbott.

EHS Responsibilities

- Ensure adherence to Environmental Health & Safety standards and regulations.
- Promote a culture of continuous improvement in EHS awareness and performance.
- Demonstrate accountability for EHS compliance through active participation in Abbott’s EHS Program.
- Ensure prompt investigation and reporting of work-related injuries or illnesses.
- Actively support Abbott’s EHS programs.

Accountability / Scope

- The position allows for decision-making within the scope of agreed responsibilities.

Education & Experience Required

We are looking for candidates with a third-level qualification in a related field and over 5 years of experience in a regulated manufacturing environment. This should include at least 2 years of people management experience within a Quality or Operations function. Experience as an auditor or lead auditor is a plus. Experience with Post market Surveillance would also be an advantage.

Key Skills

- Proven experience in the medical device industry.
- Ability to lead and manage high-profile audits.
- Strong verbal and written communication skills, with the ability to convey information clearly and effectively.
- Excellent interpersonal skills, capable of working independently and as part of a team with minimal supervision.
- Demonstrated people management skills, including managing staff, mentoring new hires, or leading training programs.
- Proactive attitude, exceptional organizational skills, and the ability to manage multiple projects while delivering results on time.
- Strong analytical, critical thinking, and problem-solving skills, with the ability to conduct root cause analyses and complete Quality Data Evaluations as needed.
- Competent knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g., ISO9001, ISO13485, ISO14971, cGMP, CE, MDD, MDR).
- Excellent computer skills, including proficiency in MS Office applications (Word, Excel, PowerPoint). Experience with Power BI is an advantage.
- Experience working with electronic quality management systems.

Connect with us at www.abbott.com or https://www.ie.abbott/, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

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