Senior QA Engineer - Groningen
For one of our leading medical devices clients in Groningen we are looking for a Sr. QA Engineer. In this role you will be establishing and maintaining quality assurance programs, procedures, and controls, ensuring that performance parameters of both the products and quality system elements are continually measured to drive improvement initiatives.
- Administers the change control program and manages local procedures and specifications in the document control system.
- Leads efforts to comply with company policies, procedures, and quality standards, as well as safety and environmental regulations.
- Develops solutions to database problems of advanced scope and complexity.
- Writing new or updated operating procedures.
- Generates, identifies, and suggests improvements in significant performance trends. Reports them to management and appropriate cross functional teams.
- Releases batches once it has been determined that all compliance and procedural requirements have been met.
- Investigates, tracks and trends customer complaints and provides complaint data for quality reports including annual drug product reviews, and monthly and quarterly complaint reports.
- Supervises external (including DEKRA/FDA) and internal audits (CQA). Addresses audit observations.
- Manages non-conformity.
- Assesses and determines specifications for raw and auxiliary materials, processes, semi-finished products, and end products in relation to internal and external quality standards.
- Investigates and resolves Corrective and Preventive actions (CAPAs).
- Reviews and approves prepared complaint reports.
- Support R&D function to ensure quality assurance within product and process development projects
- Excellent command of Dutch and English language
- Education: University/Bachelor’s Degree or Equivalent
- Work Experience: 4-6 years of relevant work experience, preferably in the pharmaceutical or medical-device industry
- Knowledge of GMP, MDD/MDR, QSR CFR 820, ISO 13485, ISO 14971, quality assurance systems (QMS), validation of technical systems and processes, statistics and quality improvement techniques and MS Office
- Location: Groningen
- Full time on site, after min. 3 days on site
- 1 year contract, possibility of extension
Interested? Send me your CV at email@example.com, Let's get in touch ASAP.
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