Medical Devices jobs in Athlone, County Westmeath

Position Summary

Improve and maintain the quality system in line with ISO 13485, Medical Device Directive (MDD), Medical Device Regulation (EU-MDR), MDSAP International Regulations (Australia, Brazil, Canada, Japan, USA) and regulatory requirements applicable to the Quality Management System (QMS).

Principal Responsibilities

• Quality System compliance to ISO 13485, MDD, EU-MDR, MDSAP International Regulations (Australia, Brazil, Canada, Japan, USA) and regulatory requirements applicable to the QMS.

• Support the implementation of Teleflex global quality system processes, including but not limited to Change Management, Training, NC, CAPA, QDAR, Auditing, and Management Review.

• Coordinate and support the Internal Audit program. Promote effective and timely completion of audits to ensure compliance to audit schedules.

• Generate, interpret, analyse, and communicate results using management tools, graphs, and reports.

• Coordinate, support and participate in external audits (including audit facing Quality System Lead when required) with Notified Bodies/ and other government agencies.

• Conduct technical reviews to ensure that the Quality System remains in compliance with all applicable laws and standards, and that the system is as efficient and effective, as possible.
• Provide Quality Systems support to all areas of the QMS, including, PMS, RA, R&D, Supplier Quality, Customer Services and Marketing Communications ensuring compliance is always maintained.

• Project Manage Quality System related project activity as required.

• Drive regional and local quality initiatives

• Delegate / Designate for Manager Quality Systems / Management Representative when required during planned and unplanned leave.

Education / Experience Requirements

• Engineering/Science degree/qualification – essential

• Medical Device experience – essential
• 5/7 years of working within a Quality environment – essential

• Lead Quality Auditor Certification – essential
• Excellent technical writing skills – essential

• Attention to detail and accuracy – essential

• Ability to work well under deadlines and pressure
• Communication skills

• Problem solving skills for developing creative solutions and meeting objectives are required.

• Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MS Project, Outlook, and Excel)
• Excellent analytical ability

• The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management

Specialized Skills / Other Requirements

• Self-driven and ability to work independently and/or as a team player

• Approachable and enthusiastic. Flexible and adaptable

• Good organisational skills with cultural awareness and sensitivity

• Good judgement and problem-solving ability and is capable of understanding the impact of decision making on both Teleflex Medical and its customers
• Strong collaboration and influencing skills – both internally and externally

• Excellent communication skills – both written and verbal

• Goal orientated for customer and business objectives

• Coaching/mentoring skills

TRAVEL REQUIRED: 5 %.

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