Sr. Quality Engineer

Client

Our client offers advice and engineering for demanding projects in the industrial and life science sectors.

University/Bachelor’s Degree or Equivalent.
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.
Knowledge of quality assurance systems (QMS).
Knowledge of relevant work rules and procedures.
Knowledge of MS Office.
Knowledge of validation of technical systems and processes.
Knowledge of statistics and quality improvement techniques.
Communicative.
Flexible and accurate.
Able to function both independently and in a team.
Excellent command of English language, proficient in Dutch.

Administer the change control program and manages local procedures and specifications in the document control system.
Lead efforts to comply with company policies, procedures, and quality standards; as well as safety and environmental regulations.
Write and assist others in writing new or updated operating procedures.
Generate, identify, and suggest improvements in significant performance trends.
Manage non-conformity.
Advise, review, and approve changes in products/processes or systems, in line with the applicable procedures.
Approve all QMS related procedures and work instructions.
Ensure continuous improvement of the focus area in response to regulatory developments, trends, deviations or other data-driven inputs.
Investigate and resolve Corrective and Preventive actions (CAPAs).
Manage the quality system.
Support engineering projects to ensure quality assurance within implementation of new processes and equipment:
Drawing up the risk management plan and report, validation plans and reports.
Addressing non-conformities within production and taking care of internal escalations.
Guiding planned deviations from the production process.