Senior Quality Engineer

The Senior Quality Engineer serves as a CAPA (Corrective and Preventive action) technical investigation expert with Supplier Quality Engineering Organization, and will lead and mentor cross-functional teams with root cause analysis using appropriate techniques, conceive solutions and implementation of changes, and devise effectiveness-monitoring strategies.The Sr. Quality Engineer will work to apply knowledge in the implementation of an integrated Quality System to ensure full compliance to regulation such FDA 21 CFR Part 820, ISO13485, ISO14971, EU MDR etc.

Vacancy information

  • The Sr. Quality Engineer serves as CAPA (Corrective and Preventive action) technical investigation expert. Lead and mentor cross-functional teams with root cause analysis using appropriate techniques, conceive solutions and implementation of changes, and devise effectiveness monitoring strategies
  • The CAPA activities includes product and process improvement in Manufacturing site as well as improvement at Suppliers using Supplier Corrective Actions process i.e. SCAR
  • The Sr. Quality Engineer assists in and conduct Corrective and Preventive Action (CAPA) identification, investigation, implementation of a solution, and effectiveness monitoring for product, process and quality system issues.
  • Monitors CAPA activities for investigations, action item implementation and deliverables
  • Navigation through CAPA software administration i.e. TrackWise
  • Document all phases of CAPA activity in compliance with applicable standards, and procedural requirements.
  • Sr. Quality Engineer maintains CAPA records in a state of audit readiness; critical review of documents.
  • Guide cross-functional teams assigned to product CAPAs to ensure verification and/or validation of corrective and preventive actions are effective and do not adversely affect the finished product.
  • Work effectively with all levels of management to ensure CAPA action plans are supported and that costs/resources needed to implement the plan are available.
  • Provide training, awareness and promote enthusiasm in the business for CAPA process.

Vacancy demands

  • At least a Bachelor’s Degree, Engineering or Science discipline preferred with strong technical aptitude.
  • Minimum 5 years’ QA experience in medical device with working knowledge of FDA 21 CFR Part 820, ISO13485, ISO14971, EU MDR
  • A solid understanding of the Corrective and Preventive process (CAPA) and its potential to drive product quality improvement
  • You have the ability and willingness to dig deeper, you have excellent organisational and effective interpersonal skills, you are critical and have attention to detail.

Organization description

ENTER colleagues work for leading R&D organizations in the high tech, medical, semiconductor, and consumer products industries. Our customers provide innovative solutions for consumer products, high- tech machines, products, materials and designs for the (inter) national industry; you’ll be part of these development teams. ENTER colleagues are working on interesting assignments in attractive high tech development environments and research institutes. Besides this we are also very active in professional development and knowledge sharing between our colleagues. Our colleagues are highly educated (BSc, MSc, PDEng, PhD) and are professionals who have passion for their profession and possess good communication skills. Personal development and contributing to the success of our customers in the long term are our goals.

Our offer

  • A very challenging job in an international healthcare organisation focussing of serving patients best recovery.
  • Salary indication of EUR 4.000 - EUR 6.325 gross per month
  • Your personal development is our priority. We offer courses or trainings needed to stimulate your career

Information

Would you like to know more about this vacancy ? Please contact René van de Pas +31 40 214 10 20 or  06-55289403.

Applying

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