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At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information, and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
Advancing possibilities for a brighter tomorrow
Purpose
Act as a member of the Boston Scientific Cork facility Quality Team. To provide expert QA support to Operations, ensuring operational goals and objectives are achieved for the plant.
Key Responsibilities
1. Drive and implement process improvements to ensure predictable processes across all product lines (e.g., Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).
2. Provide effective and responsive QA support to Operations to meet their objectives of quality, cost, and output.
3. Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed (e.g., Use of DOE studies, FMEA’s).
4. Drive and implement plant-wide quality system improvements.
5. Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g., FDA and TUV).
6. Management of Sterile Returns and IDD processes.
7. Provide functional expertise to other support functions on quality-related issues (e.g., regulatory requirements, statistical techniques, sampling principles).
8. Identification and implementation of appropriate statistical techniques to monitor process performance (e.g., SPC, CpK analysis, sampling techniques).
9. Approval of change requests for product, process, and quality system changes.
10. Customer complaints: Analysis of returns, approval of analysis reports, and analysis of complaint trends.
11. Validation: Define process, product, and test method validation requirements, preparation, and approval of Master Validation Plans, protocols, and reports.
12. Compilation of required Regulatory documentation (e.g., Technical files, Design Dossiers, Product transfer files, Essential requirements).
13. MRB: Review of MRB trends and identification of appropriate corrective actions when required.
14. Participate in internal quality audits.
15. Support the implementation of Lean Manufacturing across the site.
Education & Experience
* Minimum of Bachelor of Science Degree in Engineering/Technology.
* 2/3 years’ experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
* Experience in the medical device industry is an advantage.
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email TalentAcquisitionIre@bsci.com.
Job Segment: Medical Device Engineer, Facilities, Medical Device, Manufacturing Engineer, Quality Engineer, Engineering, Operations, Healthcare
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