BBI exists to help our customers create advances that improve health and save lives. We are seeking a Senior Quality Engineer to join our team. This is a permanent, full-time position based at our site in Crumlin. Join our team: advancing health, together.
The Role
Plan and coordinate quality programs and activities to ensure the quality and reliability of BBI products. Develop, execute and/or monitor quality plans and quality engineering tasks, as well as manufacturing process validations and controls to ensure compliance with established requirements and regulatory expectations.
Provide support for released products, evaluate product field performance and reliability recommend corrective actions, and plan for continuous improvements, as assigned.
In this role your responsibilities will include:
1. Represent Quality in product development teams/projects.
2. Attend relevant production and validations meetings as SME.
3. Work with the Quality team along with Global and Site QA/RA teams to develop & execute plans (quality plan, risk management plan) and requirements (safety, functionality, regulatory, usability) to ensure provisions for quality are addressed and resolved prior to release.
4. Coordinate with the development team, essential design control deliverables including, but not limited to product performance analysis on similar products, essential requirements checklist, design verification, design validation, design reviews, phase reviews, and product release authorisation for distribution of product.
5. Work closely with Product Development, the Project Team, Technical group, Quality Engineers to develop appropriate verifications, validations, and qualifications for both new design and changes to released product.
6. Review design inputs (specifications) and design outputs (reports, prints, etc.) to assure that appropriate design requirements are specified and to evaluate/confirm quality requirements prior to successful design transfer.
You should apply if:
7. Science Degree and/or relevant industry experience
8. Lean Techniques
9. Prior Quality Engineer experience.
10. Proven experience in medical device /pharma industry in a Quality / Engineering or supervisory role
11. Knowledge of ISO 13485 and other recognized international quality system standards (e.g. FDA QSR 820)
Our Recruitment Process
If this role sounds like it’s for you, click ‘apply’ today. Once we’ve received your application, a member of our recruitment team will be in touch to arrange a call. On this call, we’ll be able to tell you a lot more about working here at BBI Solutions, how ‘a day in the life’ of this position looks and discuss the next stages of the recruitment process.
If you are an internal employee applying for this vacancy you and your manager are required to complete an internal transfer form. This needs to be completed in full and attached to your application along with your CV and cover letter.
As part of career development and succession planning internal applicants will receive priority consideration initially, please ensure that you apply within the initial two-week period to support this.
Why Choose BBI
We are committed to promoting and protecting the physical, financial, and emotional well-being of all our employees. With our employees focused on others, we’re focused on them. That’s why, at BBI, we’re dedicated to providing our employees with access to global resources and site-specific benefits that support their health and wellbeing.
12. Competitive Salary with Yearly Salary Reviews
13. 5% Contributory Pension Scheme
14. Life Assurance (4x Annual Salary)
15. Private Health Care Scheme – including dental
16. Global Employee Wellbeing Programme
17. Reward and Recognition Programme
18. Commitment to Career Development
19. Generous Annual Leave Package
20. Cycle to Work Scheme
21. Refer A Friend Scheme
22. Subsidised Canteen
23. Free Onsite Parking
24. Electrical Vehicle Lease Scheme
25. Electrical Charging Points
26. State of the Art Facilities – Certified Centres of Excellence
We’re also focused on development, creating an environment that allows our employees to nurture their talent and empowers you to make a difference. This is achieved by providing our employees with access to learning opportunities to help achieve personal career goals.
About BBI
For more than 70 years, we’ve been perfecting reagents, both native and recombinant, to help IVD and life-science teams turn breakthrough ideas into reliable, life-saving advances.
Great products are only the start. From troubleshooting tricky performance issues and customising reagents to meeting new regulatory standards, our scientists work to clear obstacles and accelerate progress. That’s why we continue to invest millions in new recombinant capabilities that help create diagnostics that improve health and save lives - in a more ethical and sustainable way than ever before.
Equal Opportunities
BBI are an equal opportunity employer and believe in fair treatment for all candidates. Qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
We ask that all applicants complete an equal opportunity monitoring form on a voluntary basis, with all submissions remaining anonymous. The information on the form will be used for monitoring purposes only and will not be used in any decision affecting you.
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Please note that we reserve the right to close this advertisement at any time upon securing a suitable candidate.