As the Product Quality Assurance (PQA), you will be responsible for the supervision and coordination of Quality Assurance activities in the PQA group. You will ensure the assigned areas of the Global PQA group is effectively maintained and compliant with the requirements specified in The Division Quality System, and relevant international standard (e.g. ISO) and other applicable standards.

Key Responsibilities:

• Supervision and coordination of Product Quality Assurance activities with a focus on timeliness and process improvements, incl. but not limited to:
• Coordination and documentation of complaint evaluations, investigations, and approvals with Strong customer focus and using problem-solving skills
• Coordination and support of risk evaluations performed for potential Quality issues as well as subsequent field correction and vigilance activities
• Trending and tracking of complaint data and systematic evaluations.
• Support initiation of QPI’s and Quality Communications.
• Providing and presenting Metric Data for Management Review and site scorecard
• Support of the global potential RE/MDR/MDI analysis process and respective updates.
• Coordination of PQA support for R&D projects, PDMRB and post-market review activities, product transfers, or other relevant projects.
• Team Leading and Personnel Management.
• Ensures operations are performed in accordance with applicable site and Division procedures with strong attention to detail.
• Continuous consideration of process improvements and implementation.
• Continuous consideration of priority and resource management, including cross-site support.
• Ensures training and development for assigned area.
• Implementation and maintenance of operating procedures relevant to assigned area.
• Input to an investigation-, ER/CAPA- and Change Control process.
• Identifies and flags potential quality issues and works co-operatively with required interfaces, other departments, and other Abbott sites.
• Works independently on projects and process improvements.
• Subject Matter Expert for assigned area-related processes.
• Support of Internal and External Audits.
• Act as the delegate for his/her/their Manager, if assigned.
• Beyond the general legal obligation to prevent accidents, PQA Supervisor is assigned certain duties in respect to environmental protection and work safety which ties in directly with her/his position within the company. It is his/her/their task to support actively Abbott’s environmental goals, to keep the sequence of operations free of risks, and to ensure employees under her/his supervision follow the rules for safe behaviour at work.

Education:

• MSc or BSc in Engineering, Business, or related discipline, OR adequate work experience in the relevant industry such as MTA, BTA, CTA or equivalent qualification
• With MSc we will require more than 2 years of experience in IVD or similar industries
• With BSc we will require more than more than 4 years of experience in IVD or similar industries.
• With MTA, BTA, CTA or equivalent qualification more than 6 years of experience in IVD or similar industries.
• Previous people management experience is essential for this role.

Key Skills:

• Good oral and written English
• Good leadership, communication and organization skills
• Proficient in Microsoft Office (Word, Excel & PowerPoint)
• Good software and report writing skills

For further information on this role in please contact Michael Marvin on 0864409255 or email sourcing@hero.ie

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