Sr QA Engineer

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Medical Devices organization, based in Noord-Holland Netherlands.

Company that outsources design, develops and manufactures services, delivers innovative and complete end-to-end capabilities to customers.

ROLE DESCRIPTION

The Senior Quality engineer can support the growth and development of the Quality Assurance organization and assure a permanent state of quality compliance. Quality and Compliance activities from the Senior Quality engineer are on an operational and tactical level. For both the production and pre-production organization it is also required to consult on a strategical level. The Senior Quality Engineer is, if necessary, a back-up for the Quality Manager related to Metrology.

RESPONSIBILITIES

Key Responsibilities for the Senior Quality Engineer are:
- Leadership & Production strategy
- Lead or participate in (quality improvement) projects;
- Develop trainings and train employees with regard to quality and improvement subjects; Coordinate the QA-activities.
- Sustain and set-up a Quality Assurance organization including adding new (innovative) capabilities to meet changing and increasing customer needs.

Quality
- Generate, review and authorize
- Quality related documents;
- Maintain the CAPA (Corrective and preventive actions) system;
- Maintain the complaint handling system;
- Investigate deviations and NCR’s (non-conformances), by determining the root cause and implementing corrective and preventive action;
- Analyze data concerning production, processes and the quality management system and propose improvements;
- Release products, processes and equipment based on statistical data;
- Execute internal and external audits including reports.

Customer Focus
- When requested, accompany
- Customer and Regulatory Body Auditors;
- Communicate results of the KPI’s and quality goals to the Quality Manager.

Team Building
- Act as a strong team-builder both with (in)direct reports (when applicable) as well as the peer-group and quality team;
- Show professional can-do attitude towards the internal as well as the external organization and develop (in)direct reports (when applicable) into the same direction.

REQUIREMENTS

Knowledge, Skills and Experience
- Bachelor Level or Master Degree in Technical discipline
- Coaching and Management capabilities
- Good Manufacturing Practice
- Quality Management Systems (ISO13485. FDA 21CFR820, MDD 93/42EEC or similar)
- EO sterilization
- Cleanrooms/ microbiology
- Process validation
- Knowledge of Lean Six Sigma tools and project management
- Organized and structured way of working
- Good presentation/communication skills in English and Dutch
- Customer focused and accurate
- Good judgement; showing business acumen, quality, perspective and problem solving.
- Thinking in solutions, socially skilled.
- At least 5 years professional experience
- Experience in Leading a Team and Auditing
- Experience in Regulatory and Customer focused organization
- Experience in a Pharmaceutical and/or Medical Devices company.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.