Boston Scientific Manufacturing/Qualification & Validation Engineer 

Netherlands, Limburg 

391274292

About the role:
In this role you will be mainly focusing on two main topics:

Core Team Engineer.In the Rework area, medical devices with cosmetic packaging damage are being repacked and relabeled. As a Core Team Engineer, you will be collaborating closely with Operations and Quality to provide daily support on processes and equipment in a controlled manufacturing environment and improve existing processes by making use of lean principles. You will support the Project Lead in the set up of new productfamilies for Rework and you ensure that equipment, mainly printers, is qualified for use and that processes are validated.

Subject Matter Expert Qualification and Validation. (SME Q&V).As SME you are the ‘go to person’ for all things related to qualification and validation for the processes in our Distribution Center. You will:

• set and maintain our local standards, in compliance with global standards
• train, coach and support the Engineering team when commissioning new software or equipment,
• execute and support more complex qualifications and (process)validations and
• represent the Engineering department in quality audits on this topic.

Your responsibilities include:
Coreteam engineering:

• Set up and sustain processes in our Rework department
• Support Operations in daily issue handling
• Identify and lead value improvement, waste elimination and problem solution projects that drive plant and company performance improvements by using Lean Methodologies
• Perform general engineering tasks, which may include updating standards, risk management, performing time studies, documenting processes and creating and approving change requests.
• Handle NCEP’s and CAPA’s.

SME Q&V:

• Demonstrates good working knowledge and understanding of principles related to Qualification and Validation
• Understands risk management principles and pFMEA’s
• Will be audit facing in quality audits on topics related to Qualification and Validation
• Train, coach and support the engineering team with regards to the Boston Scientific Q&V processes
• Enhance and clarify the local Q&V processes in alignment with applicable standards, global procedures and guidelines.
• Perform qualification and validation for warehouse equipment, software (spreadsheet and other applications) and processes. (mainly low complexity).

Required qualifications:

• Minimum bachelor’s degree in a relevant field
• Approximately 5-8 years of experience as an engineer
• Experience in the field of medical devices or other highly regulated environment, knowledge on standards related to Medical Devices, e.g. ISO 13485, GMP cfr 21 part 820, ISO 14971 etc. is an advantage
• Experience with Equipment Qualification, Computer System Validation and/or Process Validation,
• Understanding and experience on risk management and pFMEA
• Experience in Process Improvement and Problem Solving, Continuous Improvement mindset, use of Leantools is an advantage
• Excellent communication skills, being able to communicate effectively on all levels of the organization. Being able to train and coach team members.
• Fluent in English.