Telephone: 086 8395533
Site Quality Lead
Our client, a medical device company in Galway is currently looking to recruit a Site Quality Lead for their site.
- You will be responsible for providing oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.
- You will provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations and agency guidelines to assure compliance.
- You will work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.
- You will lead audit and inspection preparation, resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of audits.
- You will co-ordinate and support all legal requests in support of government investigations and litigations.
- You will ensure the quality assurance programs and policies are maintained and modified regularly.
- You will facilitate the use of uniform standards and enable best practice sharing fostering the achievement of the company’s mission.
- We are looking for a qualified person to degree level 8 in a science, quality or engineering related discipline and desirably with a minimum of seven years relevant experience.
- You are a dynamic team player and leader and can work effectively and proactively on cross-functional teams.
- You are experienced in the requirements of global quality system regulations including ISO 13485:2016, U.S FDA QSR and MDSAP requirements, direct audit experience is desirable.
- You are an excellent communicator – a key responsibility is managing people. which includes: accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals.
For further information on this Site Quality Lead role in Galway please contact Bimi Felix on 086 8395533 / firstname.lastname@example.org
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