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QA Validation Engineer

  • Job reference: 932393
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 16/10/2020

Orion Group Life Sciences have an exciting opportunity for a QA Validation Engineer for our Multinational Medical Devices client based in the Cork area on an initial 12-month contract.

Job Purpose
The QA Validation Engineer, plays a key role in the planning and execution of validation activities related to new product introductions, product transfers, new technologies and process changes. Provides support for the validation activities associated with equipment, test methods & processes ensuring that all compliance issues and requirements of Company validation policies and procedures are addressed. Provides support for the periodic validation reviews and administration of the site validation master plan and registry.

Main Responsibilities of the role
Ensure validation activities completed comply with US and EU relations, GBSC procedures and EHS requirements.
Review and approve documents prepared by project teams, other departments and contractor organizations (e.g. protocols, reports, change controls)
Assist in development of validation strategy and validation plan for equipment and process validations.
Assist in the development of sampling plans, test plans and data analysis related to process validation.
Assist in resolution of deviations/ exceptions during qualification activities
Assist with change control activities in accordance with site procedures.
Prepare periodic validation review documentation for approval by the business units.
Maintain site validation registry.
Attend identified training, required to fulfil the role of QA Validation Engineer
Support the QA Validation team leader in driving improvements within the Validation and Change Control processes to streamline the validation activities associated with Process Changes, Product Transfers and/or New Product Introductions.
Participate in cross-functional teams as required.
Process/Quality input for validation processes and new product introduction.
Adherence to site validation procedures and regulatory requirements.
Adherence to company procedures as detailed in Quality Manual.

Desired Experience and Background of the successful candidate

Hons. Degree Quality/ Manufacturing / Engineering / Science
Minimum of 2 years' experience in Quality Assurance/Engineering within regulated industry. Minimum of 1 years' experience in Process, Equipment and Test Method Validation
Working knowledge of Quality systems (FDA/ISO) within a regulated environment.
High understanding of Validation practices including the equipment life cycle and regulatory expectations
Ability to analyze Capability data using MINITAB
Ability to interpret Engineering drawings/specifications

Familiarity in areas of various inspection techniques

Excellent interpersonal & communication skills

#medicaldevices #medical #device #13485 #multinational #product #implant

For more information on this role, call Dan on +353 868140295 or email for a completely confidential chat

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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