Quality Assurance Specialist

1 week geleden


Geleen, Limburg, Nederland DSM Voltijd
Job Title: Quality Assurance Specialist

We are seeking a Quality Assurance Specialist to support our Business Unit in engineering activities for targeted product lines. The ideal candidate will have experience with process analysis, complaint handling, corrective action management, risk analysis, and root cause analysis.

Key Responsibilities:

- Serve as 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.

Requirements:

- Bachelor's degree in an Engineering discipline (Biomedical, Mechanical, Materials, etc.), Materials Science, or equivalent undergraduate experience, 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 a plus.
- ISO 13485:2016 Lead Auditor Certification 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, understanding of GMP and standards.
- Well-developed inter-personal and teamwork skills to communicate and resolve product quality issues with R&D, Production, Engineering, and other departments.

About Us:

At DSM, we are committed to providing equal employment opportunities for all job applicants and employees. We are an Equal Opportunity and Affirmative Action Employer.

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