Quality Engineer
4 weeks ago
Wondering what's within Beckman Coulter Diagnostics? Take a closer look.
At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you'll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.
Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.
The Quality Engineer for Beckman Coulter Diagnostics is responsible for ensuring Quality Project deliverables are achieved, coordinating the creation, review and approval of non-conformance's, Equipment Change Controls, Manufacturing Documentation in support of the Quality Management System. Responsibilities also include providing Quality expertise during investigations and daily manufacturing issues driving process improvements.
This position is part of the R&D QA department located just outside Tulla in Lismeehan, O'Callaghan's Mills, Co. Clare, Ireland and will be onsite. At Beckman Coulter, our vision is to relentlessly re-imagine healthcare, one diagnosis at a time.
You will be a part of the R&D QA Team and report to the Blood Virus Quality Manager responsible for supporting cross functional teams providing Quality guidance and support to all departments ensuring Good Manufacturing Practices and Quality Systems Regulations are complied with during manufacture. You will be part of a team that develops strong, positive and beneficial working relationships and effective information flow with other departments and within the Project team and Quality department. If you thrive in a multi-functional and fast-paced role and want to work to build a world-class Quality organization—read on.
In this role, you will have the opportunity to:
- Be responsible for the support of the New Product Development Process specifically Patient Sample Manufacture within BCII.
- Support the Non-conformance processes (NCs) ensuring compliance to Quality and Regulatory Standards.
- Support creation, review and approval of Equipment and Manufacturing documentation. Initiate/review/approve document Change Controls (CCFs) and Equipment Change Controls (ECCs) ensuring Good Manufacturing Practices are maintained and comply with company procedures to support Project Deliverables.
- Review and approval/release of Batch History Records. Analyze and report meaningful quality metrics to ensure ongoing improvement programmes are put in place and continually strive for customer satisfaction.
- Represent Quality at both internal and external audits.
The essential requirements of the job include:
- Bachelor's degree (Honour's Level 8) in chemistry, biochemistry, biology or other relevant technical field with a minimum of 0-2 years' experience in a highly regulated (FDA desirable) healthcare or related environment.
- Strong team player with the ability to identify and drive quality improvements. Be competent in working independently.
- Excellent planning and organisational skills with the capacity to rapidly switch between tasks at ease.
Skills:
Quality Engineering, CAPA, NC, QA, Quality Assurance
Benefits:
Pension, Medical Aid / Health Care, Performance Bonus
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