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Brightpath Recruitment Ltd.
Office 4, Sligo Airport Business Park,
Strandhill, Co. Sligo.
Tel: 071 9128266
E-mail: jobs@brightpath.ie
Web: www.brightpath.ie

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Manufacturing Quality Engineer

Location: Roscommon
Entered: 19 Sept 2018
Salary:
Duration: Permanent
 
What’s on Offer?

Brightpath Recruitment have an opportunity for a Manufacturing Quality Engineer to join a team of experts in the design, development, manufacturing, and assembly of complex medical devices and components for a medical device company in Co. Roscommon. This company creates technologies that can save or enhance people’s lives. They have been in business for over 35 years and because they are creating components or devices that will be used to save or enhance a person’s life, there is a commitment to achieving the highest standards of quality in everything they do.

 Career

They are a people-driven company and as such, empower all employees to develop new and better ways of working and to keep growing, personally and professionally. This company is committed to improving the lives of their employees and others through better health and well-being. The Manufacturing Quality Engineer is responsible for ensuring that the Manufacturing Processes, Products, and Systems are in compliance with the requirements set out in Validations, Customer Specifications, Quality & Manufacturing Specifications, Control Plans, and relevant International Standards as applicable.

Your responsibilities:

  • Collaborating cross-functionally with various departments within the business unit. The role will also involve assisting the Quality Department with investigations into Non-Conforming Events and Complaints, by providing Root Cause Analysis and CAPA identification & implementation.
  • Update/maintenance of product regulatory requirements.
  • Training of Technicians, TPAOs, and PAOs to ensure manufacturing personnel are compliant with the requirements of the Quality System
  • Provide regulatory support for new product and support to Operations, Sterilisation and Labelling/Packaging. 
  • Review and update of Regulatory documentation to ensure compliance with current ISO standards, relevant FDA guidelines and EU Directives.
  • Process Audits of the manufacturing lines to ensure the product being manufactured complies with all requirements, and that the Equipment/Process in use complies with the relevant Standard Operating Procedures
  • Identify and suggest improvements to current equipment, processes, and procedures to streamline the manufacturing activities while ensuring high standards of quality
  • Be an active Team Member on Continuous Improvement Projects by delivering on actions committed to, critiquing current methods, and suggesting alternatives/improvements.
  • Lead Manufacturing Driven initiatives with respect to quality within the department
  • Batch Record/Lot History Review to ensure Product Compliance/GMP/GDP are as per relevant procedures prior to final QA Release.
  • Conduct Training and Competence Assessment with manufacturing personnel on changes being introduced as required
  • Ensure that all products manufactured meet the specifications, performance & quality criteria of end users, customers, regulatory authorities and the company.

Qualifications
  • Degree or equivalent in polymer, manufacturing, quality management or mechanical engineering
  • At least 4 years’ medical device/pharma and or diagnostics manufacturing experience
  • Must have a good working knowledge of production and quality system requirements in the health care industry (13485:2003 and FDA QSR Parts 820)
  • A Green or Black Belt in Lean Six Sigma would be a distinct advantage
 

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