Quality Engineer I

• Location: Cork
• Req Number: 578945 
• Contract type: Permanent

At Boston Scientific, we draw the strength from the unique talents and abilities inherent in a diverse workforce and we believe that the best and most innovative products come from an inclusive workplace where varied viewpoints are welcomed and encouraged. If you require accommodation during the recruitment process please do not hesitate to contact a member of the Talent Acquisition team for a confidential discussion.

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

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.

Purpose Statement:

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.

Key Roles & Responsibilities:

• 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 area’s 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, FMEA’s).
• Drive and implement plant wide quality system improvements.
• Ensure Regulatory compliance in area of responsibility to cGMP’s 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.
   

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

About us

Purpose and Passion – Comprehensive Benefits – Life-Work Integration – Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people lives around the world. This is a place where you can find a career with meaningful purpose – improving lives through your life’s work.

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran