Quality Engineer

Quality Engineer - P1

Work mode: Onsite
Onsite Location(s): Cork, IE
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.

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

• Supervision of Quality Technicians.
• 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 the 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.
• Validation: Define process, product, and test method validation requirements, preparation and approval of Master Validation Plans, protocols, and reports approval.
• 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.
• Perform internal quality audits.
• Support the implementation of Lean Manufacturing across the site.
• Transfer and implement product and processes from development or from another manufacturing facility.

• 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.
• Experience on an automated/high volume line an advantage.

Requisition ID: 603085

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

Medical Device Engineer, Compliance, Manufacturing Engineer, Facilities, Quality Engineer, Engineering, Legal, Operations