Our client, a medical device company in Galway are currently looking to recruit a Senior Biocompatibility Engineer for their site.
Duties & Responsibilities:
- Functioning effectively as a quality engineering extended product development project team member as part of a wider cross functional team, developing strong partnering relationships with these groups, at both the manufacturing and design sites, with a focus on biocompatibility validation and chemical characterization.
- Working with the team to design protocols to ensure that new products/ product changes are adequately evaluated/tested with respect to biological requirements to guarantee compliance to all regulatory standards.
- Support the characterization and biological risk assessment of manufacturing process changes, packaging changes and supplier changes.
- Lead process and method development activities and drive continuous improvement in day-to-day activity.
- Use and establish analysis techniques and other quality control tools to aid decision - making.
- Keep abreast of industry best practice with respect to evaluations and laboratory test methods/techniques.
- Liaise with other departments, sites, functions and vendors on a frequent basis.
- Liaising with test laboratories to issue test details for testing required and to receive test results.
- Ensuring that all required testing is completed in a timely manner and reports approved to meet project timelines.
- Supporting the Regulatory Affairs department in preparing submissions to notified bodies and addressing any questions regarding these submissions.
- Reviewing all applicable regulatory standards to ensure that requirements are reflected in internal documentation and implementing changes when standards are revised.
- Performing quality audits of external contactors and supporting audits performed by internal auditors or notified bodies.
- Manage, motivate and develop personnel within the department to achieve departmental and organizational goals.
- Minimum of a Bachelor's degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Science).
- 5-8 years' experience in a medical devices or related environment with direct experience in a QA environment (GMP regulated).
- A good working knowledge of chemistry/biocompatibility validation is desirable.
- Excellent verbal and written communication skills are essential for this role
- The ability to work alone or as part of a team.
- The ability to utilize a driven approach to problem solving.
- Experience in a related area is an advantage.
- Executes: Takes accountability for and delivers consistent decisions, actions, and results. Aligns team, allowing people to move quickly in a coordinated fashion
- Clear Thinking: Translates complexity into simplicity and articulates crisply and clearly, Creates and communicates a clear strategy/plan, Demonstrates good judgment
- Driven To Win: Passionate and driven, Makes tough decisions in difficult situations, Capacity for work
- Compliance & Integrity: Promotes and practices a culture of integrity, ethics and compliance with laws and policies. Champions implementation of compliance policies, training and monitoring programs. Expeditiously takes appropriate actions when problems occur.
For further information on this Senior Biocompatibility Engineer role in Galway please contact Nicola O'Connell on 091730022 / email@example.com
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