Our client, a medical device company in Limerick are currently looking to recruit a Quality System Specialist II for their site.
This position will function within the Quality Assurance Unit of Corporate Preclinical Development & Toxicology (CPDT) and will participate in the conduct of nonclinical laboratory investigations of medical devices and materials in accordance with Good Documentation Practices, ISO 17025, and the BD CPDT Quality System.
Quality Assurance strives to live company values as part of an action-oriented team focusing on customer requirements and process effectiveness through continuous learning, influencing of others, and dedication to achieving the highest quality results.
The Quality Systems Specialist II is accountable for support of the continued development, improvement and implementation of the Quality Systems. This position actively participates in quality guidance, product resolution decisions and problem solving techniques to promote New Product Development and provide support to project teams for process improvement and continuous improvement activities.
Primary Responsibilities and Duties:
- Responsible for utilising audit programs for internal laboratory functions and external suppliers in direct support of the overall Quality System. Quality Assurance Unit documentation/activity support applies to most aspects of the systems employed by BD CPDT for material risk assessments, material characterization, and internal/external regulated (e.g. GXP, GDP) biocompatibility testing for medical devices as described in ISO 10993 and FDA G95-1.
The primary aspect of this responsibility is Quality review of raw data and reports to verify conformance to Good Documentation Practices (GDP) and internal procedure requirements.
- Active Participation in the development, implementation and maintenance of various aspects of the BD CPDT Quality System including creating and reviewing documents (SOPs, Procedures, Methods, Protocols) in overall support of continual quality improvement.
- Support the BD CPDT Training System in order to ensure training is performed and documented in order to maintain compliance to Quality System and regulatory requirements.
- Support the BD CPDT Document Control system for all controlled documents including but not limited to Policies, Protocols, Reports and Standard Operating Procedures.
- Accompany representatives from sponsoring organizations or government regulatory agencies during site audits as necessary.
- Responsible for GDP, ISO and Quality System training.
- Responsible of Archives for all controlled records, documents and samples.
- Assist with Metrology program including maintenance of Regulatory Asset Manager System.
- Assist in management of the supplier audit and approval system, including setting audit dates with suppliers and performing audits.
- Collaborate with managers, scientists and Quality Assurance personnel to develop process improvements in order to enhance testing and workflow efficiency.
- Maintain an environment of continuous improvement and quality aligned with BD core values and strategic objectives.
- Requires a minimum of a Bachelor's Degree in a scientific discipline.
- A minimum of 2-5 years’ relevant experience or a combination of equivalent education and relevant experience.
- Moderate level of application of Quality System Standards to assigned Quality system area.
- Working Knowledge of Quality Systems Regulatory requirements and application to Company/Unit requirements
- Direct Knowledge of the ISO 17025 laboratory certification program. and requirements as they relate to laboratory testing.
- Demonstrated ability to work successfully independently as well as part of a team.
- Excellent verbal and written communication skills.
- Must have the ability to focus and to execute multiple projects and programs simultaneously while maintaining attention to detail.
- This position requires excellent organizational skills and the ability to adapt rapidly to changing priorities in a high volume scientific testing laboratory.
For further information on this Quality System Specialist II role in Limerick please contact Orla on 086 0449473/ firstname.lastname@example.org
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