Help build quality into innovative product development

Quality Assurance Officer

As a Quality Assurance Officer at Zign, you will help develop, improve and maintain our quality management system in line with ISO 13485 and ISO 9001. Together with the Quality Manager, you will support project teams across different disciplines, including supporting our design teams in meeting applicable MDR requirements, and help colleagues apply quality and compliance requirements in a practical way in their day-to-day work.

This is not a role where you only follow procedures. We are looking for someone with a proactive and practical mindset: someone who enjoys figuring things out, identifies opportunities for improvement and helps teams understand quality in practice. You will work closely with design, engineering and production teams to ensure that our products meet the right standards and expectations.

Your responsibilities
  • Improving and maintaining our QMS (ISO 9001 / ISO 13485)
  • Preparing and supporting internal and external audits
  • Working with project teams to apply standards, regulations and quality agreements in a practical way
  • Evaluating suppliers and production partners from a quality and compliance perspective
  • Translating quality data into concrete improvement actions
  • Helping colleagues apply modernstate of the art, proven quality practices

What we are looking for

You do not need to know everything yet. We are looking for someone who is curious, analytical and eager to learn, with the ambition to build a career in quality. You already have some relevant work experience and enjoy being practically involved in different topics within product development, engineering or production.

  • Higher professional education level, preferably in engineering, life sciences or another technical field
  • Approximately 1 to 3 years of relevant work experience in regulated environment, preferably Medical Devices
  • Interest in quality systems, standards and regulated product development
  • A practical, structured and solution-oriented working style
  • Good communication skills; you enjoy helping colleagues move forward

Nice to have: Experience with ISO 13485, MDR or other regulated environments is a strong advantage. Experience with product development, production, audits, supplier management, CAPA or improvement processes would also be valuable.

We especially value candidates who have worked in a smaller company or a broad role, where they have learned to take ownership, act pragmatically and pick up new topics quickly.

About Zign

At Zign, we design, develop and subcontract-manufacture medical devices and other innovative products for our customers, including applications in the medical, energy and industrial sectors. We combine design, engineering and production expertise with a network of subcontracted factories across Europe and Asia, working closely with international partners to turn ideas into reliable, manufacturable products.

To support our growth, we are strengthening our quality team with a Quality Assurance Officer. We are looking for someone with initial work experience who wants to grow further in quality, enjoys investigating topics and wants to make a visible contribution to better processes, products and collaboration.

Why this is a great opportunity

This role is ideal if you:

  • Want to build real expertise in quality and compliance
  • Want to work on physical products that make an impact, not just documentation
  • Want to learn quickly by working close to design and production
  • Want to grow into a key role within the company
What you can expect from us
  • A steep learning curve
  • Exposure to real technical and production challenges
  • A team that values ownership and initiative
  • Freedom to improve things, not just maintain them
What we offer you

At Zign, you will have the space to learn, take responsibility and make a visible impact. You will work in an environment where quality directly contributes to better products, better processes and satisfied customers.

  • A competitive salary that reflects your experience and development
  • A contract for 32, 36 or 40 hours per week
  • Flexible working hours, with the expectation that you will be in the office several days a week
  • The opportunity to work on varied and innovative projects for customers in, among others, medical, energy and industrial applications
  • Direct collaboration with experienced colleagues in design, engineering, production and quality
  • Plenty of room to develop further in quality, compliance and process improvement
  • An informal, non-hierarchical organization where initiative, ownership and practical improvements are valued
Does this sound like your next step?

Are you curious, practical and motivated to take quality to the next level? Then we would be happy to get to know you. Apply through the form below and let us know why this role is a good fit for you. Questions? info@zigngroup.com

Acquisition based on these vacancies will not be appreciated

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