Senior Quality Engineer - Limerick

Location County Limerick
Job-type Permanent
Salary €60000 - €70000 per annum
Reference 1008
Title:                             Senior Quality Engineer


Location:                      Limerick


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 postproduction 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 company 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.
 


Competencies

 
  • 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 Requirements
  • 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 13485:2016 principles of GMP and FDA QSR 21 CFR Part 820 required.


TTM Healthcare is an Equal Opportunities Employer.