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Senior Quality Engineer

  • Job reference: 930240
  • Location: Limerick
  • Salary: Negotiable
  • Job type: Permanent
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 26/02/2020

Orion Group Life Sciences have an exciting opportunity for a Senior Quality Engineer for our client based in Limerick. This is a permanent role.

Job Purpose
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.

Main Responsibilities of the role

  • 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
  • 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 the 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.

Desired Experience and Background of the successful candidate

  • 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
  • Ability to work in a fluid, demanding environment
  • Understanding and appreciation of company ethics standards
  • Thorough understanding of company processes and products
  • 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
  • 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

#Quality #Engineering #LeanSixSigma #ISO13485 #GMP

For more information on this role, call John Kelleher on +353 (0) 86 606 4309 or email for a completely confidential chat about this role and other opportunities using the reference number: 930240

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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