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Quality Engineer II, Clonmel Job

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Date: Apr 11, 2019

Location: Clonmel, TA, IE

Company: Boston Scientific

Additional Locations:

 

 

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • 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’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

Purpose:

Provide Quality Engineering support to Boston Scientific Clonmel 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.
  • Identify & lead quality projects to support PCBA Factory of the Future Production 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 product quality plans, documents and systems by creating product/quality specifications in conjunction with other product development team members. May be responsible for creating risk analyses and FMEAs.
  • Develop and/or review Process Qualifications, Test Method Validations, Gage R&R’s, Process Capability studies, Design of Experiment (DOE), production control plans.
  • Leads process improvement efforts by performing appropriate analysis methods to enhance sustaining product design and new product development.
  • 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. Could serve as auditor of areas of the BSC quality system, such as development and manufacturing, as assigned.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Must comply with requirements of ISO 14001 and BSC Environmental, Health and Safety standards and follow procedures and instructions related to these standards.

 

Qualification Requirements: 

  • Engineering Level 8 or above.
  • 2-3 years in an Engineering\Science position in a Medical Device environment.
  • Demonstrate strong leadership skills and promote quality at source.
  • Develop plans and execute on time to these plans.
  • 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).

 

 

 

About us

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.

 

Requisition ID: 443799

 


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