CAPA Quality Specialist
Location: NetherlandsSIRE® 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 Medical Devices organisation, based in Utrecht Netherlands.
Take a leading role in building and managing the CAPA system and associated deliverables
Manage product and process Corrective and Preventive Action (CAPA) investigations spanning from identifying issues (including potential) with root cause analysis through to implementing solutions, monitoring effectiveness and reporting.
Partner with SQE to document Supplier Corrective Action Requests (SCARs) and Corrective and Preventive Actions (CAPAs) arising from internal investigations.
Present CAPA plans during audits.
Report on CAPA plans and progress for internal reports and management review.
Work together with all levels of Management to ensure CAPA action plans are feasible and that resources needed for implementation are available.
Perform regular analyses and corrective action effectiveness measures for the quality system and identify opportunities for improvement.
Detailed knowledge of ISO 13485, GMP and FDA QSR
Degree in Mechanical/ Manufacturing / Medical Engineering or role related discipline
Previous experience in Six Sigma and root cause analysis
Strong analytical and reporting skills
Experienced in writing technical documentation
Fluent written and spoken English. Dutch language is not required.
Confidence working in a fast paced environment
Solution focussed with a high level of self-motivation, drive and tenacity
Able to communicate effectively with good listening skills
Willingness to travel up to 25% of the time
A very competitive salary
Competitive relocation package and assistance
Assistance for the preferential 30% tax ruling application if applicable
37 days’ holiday per year (pro rata)
Full time (40 hours per week) 8 hours per day to be worked anytime between 07:00 to 19:00 Monday to Friday
Contribution towards commuting costs
A work environment where you can develop your skills, learn from the best and be rewarded for your imagination
Free, on-site parking
Social events and team lunches
Creative office vibe with a picnic area, beanbags and ping pong table
Informal dress code, we’re all about wearing flip-flops in the summer and boots in the winter!
Meaningful work with the opportunity to make a difference
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ewout de Jong.
The Company
International Medical Device Company.Role Description
Due to growth we’re seeking an experienced CAPA Specialist Quality Engineer to join our innovative team in Utrecht and play an integral role in changing the face of our industry. Working for us you will have the opportunity to make a real difference to people’s lives. We also believe our continued success depends upon the engagement and development of our employees and we strive to provide a fun, inspiring and supportive work environment.Responsibilities
A key member of the Quality team, you will be responsible for implementing and continuously improving the CAPA process and our QMS. Key responsibilities will also include:Take a leading role in building and managing the CAPA system and associated deliverables
Manage product and process Corrective and Preventive Action (CAPA) investigations spanning from identifying issues (including potential) with root cause analysis through to implementing solutions, monitoring effectiveness and reporting.
Partner with SQE to document Supplier Corrective Action Requests (SCARs) and Corrective and Preventive Actions (CAPAs) arising from internal investigations.
Present CAPA plans during audits.
Report on CAPA plans and progress for internal reports and management review.
Work together with all levels of Management to ensure CAPA action plans are feasible and that resources needed for implementation are available.
Perform regular analyses and corrective action effectiveness measures for the quality system and identify opportunities for improvement.
Requirements
Demonstrable CAPA and Quality engineering experience within medical devicesDetailed knowledge of ISO 13485, GMP and FDA QSR
Degree in Mechanical/ Manufacturing / Medical Engineering or role related discipline
Previous experience in Six Sigma and root cause analysis
Strong analytical and reporting skills
Experienced in writing technical documentation
Fluent written and spoken English. Dutch language is not required.
Confidence working in a fast paced environment
Solution focussed with a high level of self-motivation, drive and tenacity
Able to communicate effectively with good listening skills
Willingness to travel up to 25% of the time
Other information
n addition to working on a ground breaking new product, you’ll be working in a small, friendly and highly motivated team; all ideas are welcomed and great work is rewarded. We’re also offering:A very competitive salary
Competitive relocation package and assistance
Assistance for the preferential 30% tax ruling application if applicable
37 days’ holiday per year (pro rata)
Full time (40 hours per week) 8 hours per day to be worked anytime between 07:00 to 19:00 Monday to Friday
Contribution towards commuting costs
A work environment where you can develop your skills, learn from the best and be rewarded for your imagination
Free, on-site parking
Social events and team lunches
Creative office vibe with a picnic area, beanbags and ping pong table
Informal dress code, we’re all about wearing flip-flops in the summer and boots in the winter!
Meaningful work with the opportunity to make a difference
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ewout de Jong.
Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
