PURPOSE OF THE JOB: The Senior Quality Engineer is a member of the Quality and Regulatory department and plays a key role in ensuring that the Quality Management System functions are maintained in compliance with documented procedures.
They support the QMS integration activity across the site, providing guidance and expertise to ensure ongoing compliance and continuous improvement alongside cost reduction.
This role will assist or supervise other Quality Engineers, technicians, and/or administrative personnel in the performance of their duties.
The position reports to the Senior Quality and Regulatory Manager and is based in Shannon, onsite 5 days per week, with a view to develop the right candidate into a Quality Manager within 1 year.
RESPONSIBILITIES: Stays current with external and internal quality systems standards and requirements.Management of the Design Control Process from a Quality perspective and provide assistance and guidance to the Design and Development Team on all aspects of Design Control Documentation, FMEA, Quality Agreement, and Quality Plan development.Review and approve operational, test, and validation data to establish technical specifications and performance standards for newly designed or modified products and processes, including protocol and report generation and approval.Investigate complex product quality and compliance issues (e.g.
CAPA, non-conformances, audit observations), analyze data, make recommendations, and develop reports and presentations.
Select appropriate techniques for problem-solving and make solid and consistent Engineering and Quality Assurance recommendations.
Apply problem-solving skills to deal creatively with complex situations.Identify deficiencies in quality systems and define systematic corrective actions.
Support the continuous improvement of quality system processes.Develop effective quality metrics (KPIs) and communicate results to key stakeholders.Preparation and maintenance of records associated with the Management Review process.Drive compliance cross-functionally – mentor and guide other departments where necessary, updating and creating quality procedures through the change control process to support this.Participate and support internal and external audits.Train, coach, and guide colleagues on all aspects of the Quality Management System, including owning the Quality Induction process.Assist sitewide with quality improvement programs by utilizing Six Sigma tools and Lean techniques, including the education of facility personnel on these tools and techniques.Assume responsibility for various assigned projects designed to improve product quality, reduce costs, and/or validate facility products or processes, including development and implementation of any new or required inspection methods and in-process SPC.Deputize for the Senior Quality and Regulatory Manager as requested or required.
Perform other duties as assigned based on business needs.REQUIRED QUALIFICATIONS: Excellent written and spoken English; spelling and grammar are key skills.Bachelor's degree in Quality/Engineering/Science; a Master's degree is an advantage.Level 5 or above in training or similar.Minimum 8-10 years of experience in the medical device industry with 3 years of supervisory/leadership experience.Competent working knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g.
ISO9001/ ISO13485/ ISO14971/ cGMP / CE/ FDA/ MDSAP/ ISO14001).Experience with complaint management (reporting), problem-solving, and CAPA investigations - Regulatory experience regarding the same and/or qualification in a related field.Lead Auditor qualification or considerable internal audit experience necessary.Excellent interpersonal, written, and verbal communication skills, including the ability to convey appropriate information with clarity and effectiveness.
Proactive attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.Experience of Cleanroom technology, SMT, PTH, and IPC standards.
Proficient with MS Word, Excel, PowerPoint.
Familiar with the use of online Quality Systems; QT9 is a distinct advantage.Conduct duties in line with Health and Safety policy.Experience in regulatory requirements QSR, ISO/MDR.A positive attitude is important while working in a fast-paced manufacturing environment and dealing with rapidly changing priorities, maintaining communication and a sense of collaboration with colleagues, customers, and vendors.We are an equal opportunities employer but are only accepting candidates with a right to work in Ireland currently.
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