Quality Engineer II

Quality        ·        Clonmel, IE         ·       Full time

Boston Scientific’s hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

• Remote Eligible:  Onsite
• Onsite Location(s):  Cork, IE
• Additional Locations:  N/A

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:

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 Responsibilities:

• Quality lead on value stream and quality process improvement projects.
• Lead on Preventive Quality initiatives in value stream. Driving & participating in WSVA program to support the Production Area Strategy.
• Provide training and guidance to the Quality Technicians on all internal policies and procedures.
• 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.
• As necessary, propose changes in design or formulation to improve system and/or process reliability.
• Evaluate the adequacy and compliance of systems, operations, and practices against regulation and company documentation.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Qualification Requirements: 

• Higher Level 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 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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Requisition ID: 558336

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) 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!

Job Segment: Medical Device Engineer, Quality Engineer, Manufacturing Engineer, Compliance, Medical Device, Engineering, Legal, Healthcare

Please click here to apply.