Senior Quality Engineer

Location County Limerick
Job-type Permanent
Salary Competitive
Reference 1006
Title:  Senior Quality Engineer


Reports to:  Senior Quality Manager


Department:  Quality


 


Purpose of the role:  


Responsible for quality input, review, implementation, release and performance of all phases of system, product and process realization relating to the assigned area of responsibility or Value Stream;


Product design, development and New product introduction 


Quality Management system


Manufacturing transfer, Production, product release and post-production feedback


Ensuring that the system, process and product requirements are established and kept in compliance with Customer and regulatory requirements.


 During all phases ensure effective implementation, documentation and communication meeting internal and external Customer, Auditor and Management requirements. 


Support operational and engineering activities to ensure product quality and services are achieved, maintained, and improved. 


Coaching, mentoring and supervision of other Quality team members. 


Key Responsibilities: 


Key responsibilities will include (but are not limited) to the following
  • Owns all quality aspects of system, product and process, development, production, release and postproduction feedback.
  • Responsible for ensuring that risks are identified, assessed, actioned, documented and maintained for the process/product through the entire supply chain of area of responsibility.
  • Quality lead on all related product, process and test validation during design, development, transfer, and sustaining and change management phases of the lifecycle.  Lead or support complaint evaluations and Customer interactions on high profile/complex situations to manage risk to the Patient, Customer and the business.
  • Lead multi/cross functional project teams to drive process/system improvement and achieve milestones and results. 
  • Represents Teleflex in Customer interactions in a professional, constructive and commercially aware manner. 
  • Ensures that customer expectations are managed and met in all areas of business interaction.
  • Leads Product development, new process development or process/system improvement projects achieving the required standard in quality, cost management, health and safety assurance, productivity and sales growth.
  • Drives continuous process and system improvement across the board and takes initiatives to make things better every day.
  • Owns and drives the Safety/Quality/Service/Cost Metric for the assigned area or VS.
  • Excel in the technical competence required for the role, GMP’s, QSR’s, process validation, Statistical techniques, process monitoring and control tools e.g. SPC.
  • Leads by example and demonstrates agreed behaviours.
  • Aligns goals and objective setting for the VS in collaboration with management
  • Executes on Lean/Shingo initiatives bringing everyone else on board.
  • Is committed to develop, coach, motivate self and team and supports development and growth of direct reports.
  • Leads within the team based on influencing skills without having the hierarchy of all team members
  • Proactively engages in new product development to ensure a smooth transition from development to production.
  • Builds relationships with key stakeholders in the company and addresses their needs of communication and information
  • Ensure full compliance with regulatory requirements.
  • Ensure Quality and EHS policies and procedures are adhered to at all times.
 


Competency Profile


 


People
  • Clear verbal and written communication
  • Ability to lead meetings
  • Ability to work in a cross functional team
  • Interviewing skills
  • Ability to influence employees that do not report directly
 


Strategy
  • Understand the key drivers of our business
  • Understand the impact of their job on the key business drivers
  • Basic understanding of other department’s impact on the key drivers and how all departments fit together.
 


Customers and Vendors
  • Ability to understand customer/vendor relationships
  • Ability to generate appropriate relationships with customers and vendors
  • Ability to deal with difficult customer or vendor communications
  • Ability to influence customers/vendors where necessary
 


Professional skills/knowledge
  • Degree in an engineering/ quality related discipline
  • 8+ years quality technical experience in a similar environment
  • Certified Quality Engineer, preferred 
  • Certified Quality Auditor, preferred
  • Technical report writing
  • Process validations/risk analysis tools e.g. FMEA's 
  • Statistical analysis and Statistical Process Control
  • Structured Problem-Solving techniques; green belt level 
  • Understanding of Lean Principles
  • Ability to drive projects to completion 
  • Guided by the disciplines of due diligence and compliance in all aspects of work.
  • Working knowledge of EN ISO principles of GMP and FDA QSR 21 CFR Part 820 required.
 


Specific competencies
  • Ability to work in a fluid, demanding environment
  • Understanding and appreciation of manufacturing ethics standards
  • Thorough understanding of manufacturing processes and products
Skills:


Degree in Engineering/Quality related discipline, • 8+ years quality technical experience, Certified Quality Engineer, preferred, Certified Quality Auditor, preferred

 



TTM Healthcare is an Equal Opportunities Employer.