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Manufacturing/Qualification & Validation Engineer bij Boston Scientific

  • Kerkrade

  • HBO

  • 33 - 40

For our client in Kerkrade we are searching for a Manufacturing/Qualification & Validation Engineer
 
We offer you the opportunity to unleash your full potential by working alongside a diverse and high-performing team, tackling some of the most critical challenges in the healthcare industry. With access to cutting-edge tools, training, and resources, we support your growth and help advance your skills and career. Here, you’ll receive the backing you need to progress, no matter what your ambitions are.

Wat ga je doen?

Heb jij de ambitie om onze Manufacturing/Qualification & Validation Engineer bij Boston Scientific te worden?

This position focuses on two primary areas:
 
Core Team Engineer
In the Rework department, medical devices with cosmetic packaging damage are repackaged and relabeled. As a Core Team Engineer, you’ll work closely with Operations and Quality teams to provide daily support for processes and equipment in a controlled manufacturing environment. You’ll use lean principles to improve existing processes. You will also assist the Project Lead in setting up new product families for Rework and ensure that equipment, primarily printers, are qualified and processes are validated..
 
Subject Matter Expert (SME) in Qualification and Validation (Q&V)
As the SME, you’ll be the go-to expert on all qualification and validation processes for the Distribution Center. Your responsibilities will include:
  • Setting and maintaining local standards in alignment with global standards.
  • Training, coaching, and supporting the Engineering team in commissioning new software or equipment.
  • Executing and supporting complex qualifications and process validations.
  • Representing the Engineering department during quality audits.

Key Responsibilities:
Core Team Engineering:
  • Set up and sustain processes in the Rework department.
  • Support Operations with daily issue handling.
  • Identify and lead improvement projects using Lean methodologies to eliminate waste and solve problems.
  • Perform general engineering tasks, including updating standards, risk management, time studies, process documentation, and change request approvals.
  • Handle NCEP and CAPA processes.

SME Q&V:
  • Demonstrate a strong understanding of Qualification and Validation principles.
  • Apply risk management principles and contribute to pFMEA processes.
  • Participate in quality audits related to Qualification and Validation topics.
  • Train and support the Engineering team on Boston Scientific's Q&V processes.
  • Enhance and clarify local Q&V processes in alignment with global standards.
  • Conduct qualification and validation for warehouse equipment, software, and processes (mainly low complexity).

Wat krijg je?

  • Competitive salary package (including 8% holiday pay, 13th month, and yearly bonus).
  • 30 days of annual leave.
  • Excellent pension scheme.
  • Stock purchase program.
  • Comprehensive training and development programs to enhance your career.
  • In-house gym facilities (free of charge).
  • Option to lease a (electric) bicycle.
  • Collaborative and inspirational colleagues.
  • Fast-growing, innovative environment.
  • International career opportunities.

Dit ben jij

Dit zoeken we in onze Manufacturing/Qualification & Validation Engineer bij Boston Scientific

  • Bachelor’s degree in a relevant field.
  • 5-8 years of engineering experience.
  • Experience in medical devices or other highly regulated industries, with knowledge of ISO 13485, GMP CFR 21 part 820, ISO 14971, etc.
  • Experience in Equipment Qualification, Computer System Validation, and Process Validation.
  • Proficiency in risk management and pFMEA.
  • Familiarity with Process Improvement, Problem Solving, and Continuous Improvement using Lean tools is a plus.
  • Strong communication skills with the ability to effectively engage with all organizational levels and train/coach team members.
  • Fluent in English.

Over de werkgever

As a global leader in medical technology, our client has been dedicated for over 40 years to tackling the most significant challenges in healthcare. Driven by a passion for improving lives, the company develops innovative solutions that create value for patients, customers, and employees.
A career with this employer is more than just a job – it’s an opportunity to make an impact. Professionals with strong problem-solving skills, creativity, determination, and the energy to make a difference worldwide are encouraged to get in touch with us.

Interesse?

Ben je geïnteresseerd in de functie van Manufacturing/Qualification & Validation Engineer bij Boston Scientific en wil je solliciteren? Klik dan op de ‘solliciteer’ button, wij nemen dan zo spoedig mogelijk contact met jou op om de mogelijkheden te bespreken. Wil je eerst meer weten over de vacature of heb je nog een vraag? Neem dan contact op met Edmée Peters via mail of telefoon.