We are looking for a Sr. Quality Engineer for a production facility of medical devices based in Leiden.
Are you the experienced engineer within complex manufacturing principles? Do you thrive in a GMP environment? Please get in touch about this challenging position!
Responsibilities Sr. Quality Engineer
This production plant has some severe challenges ahead since the production capacity is increasing every year. Together with your colleagues in the Quality Engineering team you are responsible for all new and existing equipment within the production facility.
In this position you will be expected to:
Support the leading of Quality Operations department to ensure all quality objectives and goals are met and help develop and drive strategic direction of the organization;
Be capable of developing junior quality engineers and quality technicians in the use of Process Excellence tools and Quality Systems to make data-driven, risk-based decisions that ensure the quality of the product;
Support and lead quality improvement projects throughout the life cycle of products, including product design and development, and manufacturing;
Utilize Quality Engineering tools and techniques to establish sampling plans, develop quality plans, conduct and participate in FMEA activities, support reliability engineering activities, conduct process and systems audits and support specification development;
Analyze routine and test data looking for improvement opportunities. Designs and implements experiments (DOE's) for process and product improvement and validation testing;
Evaluate manufacturing quality performance capability and develop criteria to monitor and improve existing processes;
Serves as a technical review for validation activities, i.e. protocols and reports;
Comprehension of the quality System Regulation (21 CFR PART 820), ISO 13485 requirements, MDD, Canadian Regulation and other applicable regulations;
Be responsible for presenting business related issues or opportunities to next management level.
Requirements Sr. Quality Engineer
Bachelor’s degree (B.S.) in engineering, science, mathematics or statistics is required;
Minimum of 3 years experience as a quality-, design or process engineer (or similair) within pharma of medical devices;
Proven knowledge of good manufacturing principles and practices, and procedures;
Proven influential, leadership skills, and able to work on multi-functional teams;
Able to communicate optimally within diverse interdepartmental groups;
CQE certification, Six Sigma Blackbelt or Greenbelt certifications are preferred.
The offer Quality Assurance Engineer
You will join an innovative biotech company with a global presence. You will work in multidisciplinary teams of dedicated and talented individuals with a common goal: to make the world a healthier place!
Gross salary is depending on knowledge and experience and will be between €60k and €70k yearly. The company has attractive secondary conditions which we will would like to tell you in a personal conversation.