Quality Engineering Manager

Job description

JOB DESCRIPTION:

About Abbott

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Abbott in Ireland

In Ireland, Abbott employs almost 3,000 people across 11 sites. Abbott has six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third party manufacturing management operation in Sligo. It has commercial and support operations in Dublin and shared services in Dublin and Westport. Abbott serves the Irish market with a diverse range of health care products including diagnostics, medical devices, nutritionals and branded generic pharmaceuticals. Abbott has been operating in Ireland since 1946.

Abbott Ireland Diagnostic Division – Sligo:
Abbott Diagnostic's is a global leader of in vitro diagnostics with approximately 70,000 institutional customers in more than 100 countries. Our diagnostic products offer a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks, physician offices and clinics.

Abbott's diagnostic products offer customers automation, convenience, cost effectiveness and flexibility. Abbott has helped transform the practice of medical diagnosis from an art to a science, helping to create the modern diagnostics industry through the company's commitment to improving patient care and lowering overall costs. The history of Abbott Diagnostics is filled with examples of first-of-a-kind products and significant technological advancements.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and

We currently have a vacancy for a Quality Engineering Manager and this role will involve the following:

Objective

To ensure that the AIDD, Sligo Plant meets it's Customer, Division, Regulatory and Plant Quality goals through the effective management of the Quality Engineering department.

Primary function

The incumbent ensures the Quality Engineering group are effectively managed and all elements are in compliance with the requirements specified by Abbott Diagnostics Division Quality System and in the relevant applicable international standards.

Environmental Health and Safety

Ensure Environmental, Health and Safety standards are met and all EHS regulations and procedures are adhered to. Foster an awareness of Environmental Health & Safety in the plant and promote a culture of continuous improvement.

Reporting

This position reports to the Quality Manager/Site Quality Head with a dotted line reporting to Strategic Program Managers and/or BEx and Portfolio Manager.

Supervisory/ Management Responsibility

The position has responsibility for managing several direct reports in the Quality group, whom in turn may have supervisory responsibilities. Additionally, the position will require a managerial role in the following areas:

• Frequent contacts with Abbott personnel at many levels, Division, Affiliate and other plants.

• Close contact with plant personnel at all levels.

• Participation at Management level in AIDD.

Demonstrate Management competencies as follows:

• Team Leadership

• Set vision and strategy

• Build organisation and inspire people

• Know the Business and drive for results

Direct Reports: 2-20

Indirect Reports: 2-20

General Quality Responsibilities:

• Through the effective management of the Quality group, ensure that the plant meets the quality requirements of its customers, ADD, Corporate, ISO and IVDD Auditors and other external agencies.

• Complete all activities in a safe manner, ensuring that any potential safety issues and areas for improvement are addressed.

• Ensure Environmental Health & Safety standards are met and all EHS regulations and procedures are adhered to. Foster an awareness of Environmental Health & Safety in the plant and promote a culture of continuous improvement.

• Ensure Environmental procedures e.g. recycling, waste minimization is adhered to and improvements made where possible.

• Assist in the successful transfer/launch and start up of new products at AIDD Sligo.

• Participate, input and approve relevant NCRs, Investigations, CAPA's, Internal Audits and ensure defined corrective and preventative action address root cause, are value added and are performed in a timely manner.

• Ensure prompt attention of the Site Quality Head in areas of risk, which may have an adverse effect on product quality/performance, project completion and/or safety. Assist and advise on pertinent Quality issues as they arise during plant operations.

• Participate as required in Quality Improvement Planning and provide guidance and leadership for improving and developing the processes within the Quality area.

• Participate in site Review Boards and provide relevant metrics/data for area of responsibility as required.

• Keep abreast of developments in quality and regulatory areas to ensure the plant continues to produce quality products under regulatory compliance.

• Maintain financial budget allocation to ensure area operates within agreed plans.

• Issue an area monthly report to the Site Quality Head.

• Annually, complete performance reviews/appraisals and growth plans for direct reports.

• On an annual basis, establish with Site Quality Head, the functional goals for area of responsibility. Update and review progress against goals on a quarterly basis.

• Management of Initiation, approval, distribution and timeliness of any required Risk Evaluations, Customer Communications or Field Actions. This activity will be coordinated in conjunction with the technical groups responsible for complaint investigation.

Area specific responsibilities:

Develop, support and manage the Quality Engineering group at the AIDD Sligo site including Validation / Calibration / Quality Approval /Risk management.

Lead the rollout of the S-VMP and on an ongoing basis all site validations.

Provide guidance and approval for all quality engineering decisions in AIDD Sligo.

Leadership Activities

• Link the team's vision to that of the organisation mission.

• Seek appropriate input before making decisions.

• Build an effective team.

• Provide clear direction and define priorities.

Ability to:

• Communicate with all levels of management, internally and externally and with regulators/auditors/customers.

• Communicate with Team.

• Recognise and reward effort.

• Resolve conflict constructively

• Seek feedback

• High level of contact with other Abbott sites and external agencies and regulators.

Minimum education requirements are:

A third level degree qualification in Science, Engineering or a relevant Quality discipline. This will provide the basic understanding in the technology, analytical skills and scientific/engineering principles relevant to the role and the ability to apply them.

Experience/ Background

Required: Five years post-graduate experience in commercial health care product manufacture/QA.

Preferred: Two years experience in the development or support of a Validation / Calibration systems. 2-3 years experience in a Health Care Company preferably working with diagnostics.

This will provide the basic understanding and a foundation in the disciplines, techniques and the basic knowledge required for the position.

Problem solving

• The incumbent is expected to use own initiative in tackling and resolving problems related to issues as they arise.

• Expected to give direction and leadership in area of responsibility or as requested to other site functions.

• Seeks advice on major issues from peers and manager within AIDD and ADD Management at other sites.

• This position is crucial in identifying any causes of non-compliance of the quality system while maintaining effective communication with all and assisting in developing solutions.

Accountability

The position impacts directly on plant and product quality and thus the financial and regulatory exposure of decisions could be significant.

Scope of Authority

The position has a wide scope for decision-making within confines of agreed impact goals and budgets. Management/guidance is received through one on one meeting with Site Quality Head. Periodic goal reviews, annual performance and career development reviews will also occur.

Discover why candidates choose a career at Abbott Ireland here

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES: