Quality Engineer II

Quality Engineer II

For dsm-firmenich Biomedical, we are looking for a Quality Engineer II who is accustomed to working closely with customers and various functions within the company. If you have experience with process analysis, complaint handling, corrective action management, risk analysis, and root cause analysis, let’s connect!

As a Quality Engineer II, you will support the Business Unit regarding engineering activities for targeted product lines. This includes leading qualifications, designing, leading, and reporting validations, data analysis, statistical process control (SPC), CAPA, KPIs, review, and trending. You will be responsible for product-related root cause analysis, process mapping, and impact assessments for change control.

"At dsm-firmenich, being a force for good is not optional. Diversity, Equity & Inclusion is a shared responsibility woven into our daily work, benefiting our People, Customers & Communities, and driving business value. Equal access to opportunities is a given, belonging is a shared feeling, authenticity is celebrated."
John Doe, Inclusion Advocate

Key Responsibilities

• Expected to serve as the primary contact with business unit customers of all sizes within platform expertise, including communicating data, reports, conclusions, and changes.
• Analyze non-conforming materials and returned goods and recommend disposition and corrective actions.
• Interface with vendors and customers as required: supplier management, customer audits, complaint handling.
• Input to design, execution, and reporting of validations including Operational Qualifications, Process Qualifications, Measurement System Analysis, and Test Method Validations.
• Assist with product development and in the transition of development products and projects.
• Adhere to Quality System procedures, ISO 13485, 21 CFR Part 820, and current regulatory standards.

We Bring

• The opportunity to really contribute to improving people’s lives and solving the challenges of today’s world.
• A safe and inclusive workplace.
• A learning environment where you can develop yourself and your team to the next level.
• A good Collective Labor Agreement and competitive salary.
• In the Netherlands, based on your experience, we will offer you a base salary of € 57,829 to € 95,007 per year (based on full-time, including holiday allowance and 13th month) and extra benefits (25 holiday days, 6% MyChoice Budget, bonus, etc).

You Bring

• Bachelor’s degree in an Engineering discipline (Biomedical, Mechanical, Materials, etc.), Materials Science, or equivalent undergraduate experience. A master’s degree is a plus.
• 2-6 years of Quality Engineering within a QA/QC department at an FDA-regulated, Medical Device, Pharmaceutical, Biotech, or other regulated industry.
• Lean Six Sigma or ASQE Certification is a plus.
• ISO 13485:2016 Lead Auditor Certification is a plus.
• Proficient use of statistical techniques and software (e.g., Minitab).
• Experience with ISO 9001, or ISO 13485, or 21 CFR Part 820 desired, and an understanding of GMP and standards.
• Well-developed interpersonal and teamwork skills to communicate and resolve product quality issues with R&D, Production, Engineering, and other departments.

Equal Opportunities Commitment

dsm-firmenich is fully dedicated to inclusion because when people feel engaged and empowered, their creativity and innovation drive unprecedented progress. We aim to build a workplace where opportunity really is equal, so everyone can thrive. We do not discriminate; there’s a place for everyone at dsm-firmenich.

For further information, please contact Julita Straszak, Talent Acquisition Business Partner at julita.straszak@dsm-firmenich.com.