Boston Scientific Quality Engineer P2 

Ireland 

529735888

Advancing possibilities for a brighter tomorrow

Purpose Statement:

Provide Quality Engineering support to Boston Scientific Clonmel Neuromodulation Implantable Pulse Generator commercial and development manufacturing lines ensuring delivery of the highest quality product to the customer while supporting continuous improvement projects and quality initiatives. Partner with product development teams to provide quality engineering support and help ensure development of highest quality new products. This position requires interactions with multiple value streams and may also require interactions with multiple divisions across Boston Scientific.

Key Roles & Responsibilities:

• Quality lead on value stream and quality & cost process improvement projects.
• Identifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventive actions.
• Lead on Preventive Quality initiatives in value stream. Driving & participating in WSVA program to support the Production Area Strategy.
• Collaborate cross functionally with local and divisional team members on assigned projects to ensure quality compliance.
• Identify & lead quality projects to support production unit area strategy.
• Coordinates and conducts technical investigation and documentation of non-conforming events and trends, and develop technical investigation plans using Engineering Essentials. Investigates and analyse customer/internal complaints.
• Ensure Regulatory compliance in projects of responsibility by utilising quality tools and processes (PFMEA, Risk reduction, process change analysis).
• Ensure that corrective and preventive measures meet acceptable reliability standards. Analyse preliminary plans and develop reliable engineering programs to achieve company, customer, and governmental agency reliability objectives.
• Develop and/or review Process Qualifications, Test Method Validations, Gage R&R’s, Process Capability studies, Design of Experiment (DOE), production control plans.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Education & Experience:

• Honours Degree/Level 8 qualification in Engineering/Quality/Science with a minimum 2 years’ experience in a Medical Device environment or related industry.
• Demonstrate strong leadership & communication skills and promote quality at source.
• Strong Project Management skills combined with proven consistent execution within committed quality, time, and cost targets.
• Experience/training in problem solving and process improvement methodologies (Engineering Essentials).

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