Senior QA Engineer

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.

Responsibilities:

•  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

Your profile:

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

Practicalities:

Location: Groningen

Full time on site, after min. 3 days on site

1 year contract, possibility of extension

Interested? Send me your CV at t.romondt@panda-int.com, Let’s get in touch ASAP.

Know someone interested? Introduce me to her or him. Refer a friend and earn €250,-.