Quality Engineer P2

Cork - Ireland

Monthly Salary: Not Disclosed

Posted on: 3 hours ago

Vacancies: 1 Vacancy

Job Summary

Additional Locations: N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific well give you the opportunity to harness all thats 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 well help you in advancing your skills and career. Here youll be supported in progressing whatever your ambitions.

Purpose Statement

Act as a member of the Boston Scientific Cork facility Quality Team. To provide expert QA support to Process Development and Operations in ensuring operational goals and objectives are achieved for the plant.

Key Responsibilities

Provide effective and responsive QA support on development ramp up or transfer of production lines from another manufacturing facility with a focus on risk mitigation.
Provide quality expertise in the development of production lines to meet cGMP requirements including approval of procedures FMEAs cleanroom practises etc
Drive compliance to validation requirements for new product introduction. Define process product and test method validation requirements preparation and approval of Master Validation Plans protocols and reports approval.
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).
Provide effective and responsive QA support to Operations to meet their areas objectives of quality cost and output.
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 FMEAs).
Drive and implement plant wide quality system improvements.
Ensure Regulatory compliance in area of responsibility to cGMPs of all medical device regulatory agencies(e.g. FDA and TUV).
Provide functional expertise to other support functions on quality related issues(e.g. regulatory requirements statistical techniques sampling principles).
Identification and implementation of appropriate statistical techniques to monitor process performance(e.g. SPC CpK analysis sampling techniques).
Approval of change requests for product process and quality system changes.
Customer complaints: Analysis of returns approval of analysis reports and analysis of complaint trends.
Compilation of required Regulatory documentation (e.g. Technical files Design Dossiers Product transfer files Essential requirements).
MRB: Review of MRB trends and identification of appropriate corrective actions when required.
Support the implementation of Lean Manufacturing across the site.

Education & Experience

Minimum of Level 8 Honours Bachelor of Science Degree in Engineering/Technology.
3/4 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.

Requisition ID:618167

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 (NYSE: BSX) isnt just business its personal. And if youre 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!

Additional Locations: N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific well give you the opportunity to harness all thats within you by working in teams of diverse and high-performing employees tackling some of the most important healt...