NPI Quality Engineer

NPI Quality Engineer New Product Introductionfor Manufacturing of Microelectronic

Do you want to become part of one of the worlds leading companies within hearing Healthcare

Do you have a passion for quality and compliance in high-tech manufacturing

Would you like to be part of product development and readiness to production

If so you may find a rewarding opportunity within our Quality Team at Demant.

About Demant

Demant develops and manufactures cutting-edge hearing aids that improve the lives of people with hearing loss around the world. Our Ballerup site is the global competence center for microelectronics and the main production hub for amplifiers used in our hearing aids.

We are committed to excellence in manufacturing and continuously invest in state-of-the-art technologies to ensure premium product quality.

We are looking for an NPI Quality Engineer with a commitment to high technology who thrives in a challenging production setting. You will play a key role in ensuring new products and processes are following internal procedures and regulations. With your adept collaboration skills and commitment to maintaining product quality in regulated environments you will be an essential part of our microelectronic production process.

Your Role: Quality NPI Engineer

As an NPI Quality Engineer you will be a key contributor in ensuring that new microelectronic designs meet the highest quality standards before entering to volume production. You will work closely with cross-functional teams to secure robust quality processes and compliance throughout the product lifecycle. Supporting day-to-day quality activities related to volume production will be part of your role as well.

Your key responsibilities will include:

• Ensure compliance with Medical Device regulation (MDR) ISO 13485:2016 Medical Device Single Audit Program (MDSAP) and other relevant regulatory standards applicable to medical device industry.
• Participate in design reviews meetings review requirements for manufacturing and support design transfer to volume production.
• Ensure Device Master Record for the products are in compliance with our local and global release processes.
• Drive risk assessment through Process Failure Mode and Effects Analysis (P-FMEA). Review and identify needed control points on work instructions based on P-FMEA analysis (establish mitigation).
• Support with non-conformity root cause analysis and corrective/preventive actions (CAPA).
• Support internal and external audits.
• Collaborate with cross-functional teams to improve production yield and quality processes support to production.
• Support to monitor and analyze Quality KPIs for NPI production and distribution and drive portfolio of improvement activities.
• Maintain and improve quality documentation and systems.
• Support on validation reviews.

Cross-Functional Collaboration:

• Collaborate with NPI Project Managers Software and Process Engineers R&D teams and Production to ensure quality standards are met throughout the product lifecycle.
• Interface with external suppliers to address and resolve quality issues related to components ensuring timely and effective corrective actions.

What We Offer

When joining us you will be introduced to an onboarding plan with a thorough introduction program. For us it is essential that you get a proper introduction to your new role and learn about the different business areas.

You will also be assigned to a mentor from the team who will make sure you get all the necessary information about how we work and the new surroundings.

We promote a diverse and inclusive culture that values your input with a high focus on your well-being supported by health programs and a positive work atmosphere. We are committed to our employees well-being and you will get the opportunity to join different social activities clubs fitness etc.

We encourage you to develop your career. If you wish you can advance your skills pursue a specialized career path or perhaps take on a new role. Of course it all depends on timing as well. But as you may sense we would like to keep you in Demant for as long as possible.

As the job is onsite Ballerup it is important you can start here from day one. We have a flexible work setup and working from home is possible.

We expect around 4-10 days of traveling to Poland per year for team building training purposes or just for you to know about the different business areas and teams you will be collaborating with.

The Quality Team in Ballerup

You will join a team of four people including your manager. Each team member brings unique skill sets and knowledge but all work together to ensure compliance and safety of our products. The team values effective teamwork where knowledge is shared openly and help is only a desk away. While we maintain a professional work atmosphere we look after each other and like to share good laughs histories and experiences.

Could We Be a Match

Were looking for someone with:

• Relevant Technical background in Quality or Biomedical Electronics Industrial Engineering or similar.
• Minimum 3 years of experience in Quality and compliance on manufacturing environment for medical devices.
• Understanding of regulatory requirements and quality systems (e.g. MDR ISO 13485 FDA 21 CFR Part 820 MDSAP).
• Experience in Audit environment.
• Demonstrated collaboration and problem-solving abilities (Fishbone 5 whys).
• Knowledge of risk management and validation is a plus.
• As you will be part of an international work environment you are fluent in English; oral and written.
• Highly effective communication and documentation skills.
• Problem-solving mindset and attention to detail.

Ready to Join Us

Submit your application and CV no later than 16th November 2025.

We expect to hold 1st interviews on 18th and 19th November and 2nd interviews on 27th and 28th of November.

If you need more information please reach out to Ana Valente Teamlead Quality at .

Please note we do not accept applications from external recruiters and we only accept applications via our recruitment systems.

We look forward to hearing from you!

At Demant we value diversity equity and inclusion (DE&I) and we are committed to creating an inclusive working environment. We welcome applications from alle qualified candidates regardless of ethnic background personality age gender and education. Diversity is part of our cultural DNA. Women in STEM areas are particularly encouraged to apply as Demant supports United Nations Sustainable Development Goal 5 on gender equality.#LI-HYBRID#LI-BS1