Quality Engineer

Overview
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.
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).
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 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
At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative.
It is essential in advancing science for life and improving patient health.
We stand for inclusion, equality, and opportunity for all.
By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.
Boston Scientific is proud to be an equal opportunity and affirmative action employer.
Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability.
Should you require a reasonable accommodation during the recruitment process, please email
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Medical Device Engineer, Quality Engineer, Medical Device, Business Process, Engineering, Customer Service, Healthcare, Management
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