applications

BASIC FUNCTION:

The purpose of this role is to be the company's expert on the application and practice of microbial assurance and biological evaluation programs for medical devices. Additionally you will act as a support to R&D, manufacturing and quality teams in providing expertise and guidance on microbial assurance in the monitoring of Sterilized medical devices. You will support efforts to ensure that the company meets all corporate, FDA, Department of Health & Medical Device Directive and European Standards requirements.

RESPONSIBILITIES:

To oversee/co-ordinate use of all microbial services, review and develop procedures for all microbial assurance activities.

To co-ordinate and complete biological/biocompatibility testing and evaluations for product ranges as required.

To be a member of New Product Development teams and undertake microbial, sterilization validation, and biocompatibility testing of new products as required.

To carry out regular intern al auditing of all Environmental controlled areas, Lead ECA Re-certification activities including review and approval of associated documents.

To regularly audit the sterilization subcontractors, contract laboratories and clean room clothing suppliers.

To implement the GMP training programme for environmental controlled areas and other appropriate staff.

To keep abreast of alternative sterilization technologies for the site that could be applied to products.

To implement the microbial assurance aspects of the Quality System

SUPERVISORY RESPONSIBILITY:

None

SKILLS REQUIRED:

Demonstrated experience in auditing contract sterilization suppliers

Ability to work on own initiative with minimum supervision

Good interpersonal Skills and an ability to deal with all levels of the organization.

Clear understanding of Sterilization and Biological Evaluation regulations for medical devices.

Clear understanding of cGMP for Environmentally controlled rooms.

Knowledge of both the FDA and ISO regulations for medical devices

EDUCATION/TRAINING REQUIRED:

Degree level qualification in Science or Engineering equivalent

Familiarity with microbiological aspects of GMP regarding sterile medical devices

Experience of conducting GMP audits, internal and relevant external audits ideally qualified as a lead auditor.

Experience in dealing with HVAC systems is desirable.

EXPERIENCE REQUIRED:

Minimum 3 years post qualification experience in a Quality role within a medical device, pharmaceutical, or similar regulated industry.

If you are interested in applying for this position please forward your updated cv as soon as possible.

Eileen Nyhan to jobs@brunel.ie