On behalf of my client, a global medical device company we are working with them on a new opportunity for a Technical Services Manager:
Reporting to the Director of Operations, this role is the senior technical role responsible for the current portfolio of on market products manufactured at the site. You will drive product improvement, sustainability and technical support for a modern, high volume, automated manufacturing facility.
Role and Responsibilities
· Leadership and management of the Technical Services Team.
· Being the technical SME for the “on market” product portfolio.
· Ownership of the technical aspects of Design Changes, NCMRs, Change Controls and CAPAs for on market products.
· Driving improvement and sustainability projects to support manufacturing of existing products.
· Working with the New Product Introduction (NPI) Group to take technical ownership of new products as they are transferred from R&D to commercial manufacture.
· Developing the capabilities of their team through training and coaching.
· Participation as technical lead in cross functional site management activities.
· Adherence to the Quality Policy and certified QMS.
Skills and Behaviours:
· The successful applicant must be agile, diligent and possess an analytical approach to problem solving.
· Be a clear communicator, open contributor, and flexible thinker.
· An ability to motivate members of their own team and build relationships with all functional departments.
· A willingness to collaborate with and influence individuals and groups in a positive, teambased environment.
· They will pay attention to detail and work with a sense of urgency to resolve time critical issues.
Education and Experience:
· BSc in Biological/Biomedical Sciences, Microbiology Biotechnology, Biochemistry or Chemistry is essential.
· MSc/PhD preferable.
· A minimum of 5 years’ experience within the IVD industry, ideally in technical product improvement and/or product manufacturing roles.
· Practical hands- on experience in a wide range of immunoassay technologies specifically lateral flow test technologies.
· Experience managing key processes within an ISO13485 certified QMS, specifically Design Control, Design Change, NCMR resolution.
· Experience in leading technical teams and interfacing with relevant cross functional departments to identify and drive process improvements.
· Demonstrated competence in a wide range of statistical concepts.
· Experience with FDA / HPRA Regulatory requirements and audits.
For a full Job Spec and to apply for this role please call Katie on +353 1 895 5770 or e-mail email@example.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671