(Senior) Quality Engineer

Location: Netherlands

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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!Our client is a professional Pharmaceutical organisation, based in Zuid-Holland Netherlands.

The Company

The company is dedicated to bringing meaningful innovation to global health. Their teams focus on the discovery, development, manufacture and marketing of vaccines and antibodies to protect people worldwide from infectious diseases.

Role Description

- Optimize systems and processes that are aligned with Mentor’s strategy and mission effecting continuous quality improvement.

Responsibilities

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

- Supports, consults, trains on, and leads quality improvement projects throughout the life cycle of Mentor products this includes product design and development, manufacturing, purchasing and improvements;
- Utilize statistical tools and techniques to establish sampling plans. Supports engineering activities in process and vendor specification development;
- Analyzes process-, product-, test- and Quality Management System data and investigates for improvement opportunities;
- Responsible for pFMEA documentation and leading pFMEA meetings;
- Reviews validations documentation (eg. IQ, OQ, PQ and verification studies);
- Leads or is team member of CAPA investigation and action plans;
- Leads or is team member of Internal audit observation investigation and action plans;
- Investigate instances of nonconforming material and supports the determination of cause, corrective action and recommendation of the disposition of product;
- Ensures that software validations are performed according to applicable FDA guidelines. Provides end user support by software validation throughout the Software Validation Life Cycle at The Netherlands Operations;
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

Requirements

- Able to work on cross-functional teams is required. Must also be able to communicate effectively within diverse interdepartmental groups;
- Six Sigma Blackbelt or Greenbelt certification preferred;
- Strong plus: experience in microbiology sterilisation;
- Bachelor’s degree (B.S.) in engineering, science, mathematics or statistics is required;
- A minimum of three years related manufacturing experience and/or training; or equivalent combination of education and experience is desired;
- Demonstrated knowledge of good manufacturing principles and practices, and procedures.

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