Senior Quality Engineer

Senior Quality Engineer
 
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 on-going compliance and continuous improvement alongside cost reduction. 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 the role is based in Shannon, onsite 5 days per week, hiring 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, 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. Protocol and Report, generation, approval.
• Investigate complex product quality and compliance issues (e.g. CAPA, non-conformances, audit observations), analyse data, make recommendations and develop reports and present. Select appropriate techniques for problem solving and make solid and consistent Engineering and Quality Assurance recommendations. Applies problem-solving skills in order to deal creatively with complex situations. Identifies problems and possible solutions and takes appropriate action to resolve. (5 Whys, 8D, A3)
• Identifies deficiencies in quality systems and defines systematic corrective actions. Supports the continuous improvement of quality system processes.
• Develops effective quality metrics (KPIs) and communicates results to key stakeholders. PowerPoint ready.
• Preparation and maintenance of records associated with the Management Review process.
• Drives compliance cross functionally – mentors and guides 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 Quality Management System, Including own the Quality Induction process.
• Assists sitewide with quality improvement programs by utilising Six Sigma tools and Lean techniques, including the education of facility personnel on these tools and techniques.
• Assumes 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.
• Deputise for Senior Quality and Regulatory Manager as requested or required. Performs 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– Masters degree an advantage.
• Level 5 or above in training or similar.
• Minimum 8-10 years of experience in 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 same and/or qualification in related field.
• Lead Auditor qualification or considerable internal audit experience necessary.
• Excellent interpersonal, written and verbal communication skills, including ability to convey appropriate information with clarity and effectiveness. Pro-active attitude, excellent organisation 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, Power Point. Familiar with use of online Quality Systems; QT9 a distinct advantage.
• Conducts 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.