Senior QA Engineer (Sterilisation)

Job type: Permanent
Salary: £55000 to £70000
Contact name: Barry Usher

Contact email: barry@macrorecruitment.ie
Job ref: 32068
Published: 3 months ago
Startdate: 06/07/2022

JOB SPECIFICATION

 

Our client is a leading provider of complex extrusions, finished catheters and devices to the minimally invasive medical device industry.

Specialising in providing design and manufacturing expertise for a wide variety of extrusion and catheter based medical devices, the Company operates from three facilities with a team of over 400, operating in a combined work space of over 150,000sqft.

Job Title/ Position:

Senior QA Engineer (Sterilisation)

 

Required Qualifications/Experience/Skills:

 

Degree in Quality / Technical with emphasis on Medical Device Industry

Minimum 5yrs previous experience in Quality/Validation in Medical Device/Pharma Environment, with knowledge of sterilisation processes – EO and Irradiation.

 

Duties/ Accountabilities (incl. Deputation):

 

This involves but is not limited to:

 

  • SME for sterilisation processes for new product introductions (NPI) and maintenance of existing validated sterilisation cycles within the site(s).
  • Participation in the new product introductions programme to ensure that they are effectively introduced in accordance with the requirements of ISO 13845 and GMP.
  • Participate and assist with other validations that can impact on the sterilisation processes, such as packaging validations for example.
  • Work to develop standard company cycle at steriliser. 
  • Carry out other NPI activities in relation to QA / QE activities as required to support the NPI / R&D processes.
  • Participation in the Customer Complaint investigation process and participation in routine failure investigation & process trouble-shooting for all issues reported in cleanrooms 1 & 2.
  • Participation in the Plant Corrective Action Programme
  • Participation in the Internal Quality Audit Programme
  • Work with other Company sites as required to support sterilisation activities as required.
  • Participate in the alignment of a “one global” sterilisation procedure for all Company sites.
  • Work with the site(s) head of quality to determine the suitability of developing in-house sterilisation processes.
  • Adhere to Plant Safety requirements and Health & Safety requirements relating to your work, assuming responsibility for those aspects of the OH&S System over which you have control to ensure the health and safety of yourself and others.
  • Be aware of the potential environmental impacts associated with your work and the implications of non-conformance.
  • Contribute to enhanced energy performance by conservation of energy where possible (Lighting, Equipment, Air Conditioning etc).
  • Contribute to the continual improvement activities of the OH&S, Environmental and Energy Management systems through participation, providing feedback/ suggestions for improvement and by reporting accidents, dangerous occurrence, near miss/ illness, good catch and environmental incidents in a timely manner.