Design Assurance Engineers
Requisition Number: n/a
Countries: The Netherlands, Finland, Czech Republic
Cities: Hillegom, Lehmo, Trhove Sviny
time position based in our offices
in The Netherlands , Finland and Czech Republic
The Design Assurance Engineer provides input to our contract development
teams in the design of medical devices. They ensure that compliance to customer
and regulatory requirements is demonstrated and help to ensure successful
transfer of the design to manufacturing. They are responsible for accurate,
independent evaluation of Design History File documentation and overall Quality
System compliance. Reporting and
operating under the direction and guidance of the Design Assurance Manager,
based in Hillegom, The Netherlands.
Qualifications - Education & Experience
Key Responsibilities for the Design
assurance Engineer are:
Review and approval of disign verifiaction related documantation including any additional activities e.g. testing for those projects where Phillips-Medisize has designer responsibility, process and equipment verifivation against the respective URSs (e.g. SAT, DQ for jigs, mould tools, assembly equipment etc. Ensures that all project related documetns are created and well managed according to the regulation and internal quality stdanderds.
Approves quality documents related to the NPI and DDC Process
Guides the execution of (process) vlaidations and associated tests to be performed in the pre-production phase in close collaboration with other related/relevant disciplines (including review and approval of documentation).
Ensures all project and quality documents are complete, current and stored appropriately.
Leads and partivipates in risk management sessions.
Approves quality documents related to the design assurance projects.
- Manages and monitors day-to-day project documentation Identifies required capabilities and resources in support of the project scope and deliverables
- Participates in development in the area of project management, product development, process development and tooling
- Participates in (CMO) design review sessions
- Develops and improves the effectiveness of projects and processes under his/her responsibility
- Reports project status to Manager Design Assurance and Project Manager
Customer and Supplier relations:
- Selects applicable regulation based on the intended use of the product, its classification and customer requirements stipulated in mutual agreement with the customer
- Manages correct project documentation with customer and suppliers
- Communicates project status to customers
- Ensures a smooth transfer of the project documentation from Pre-Production stage into Final Production stage
Qualifications - Skills & Competencies
Knowledge, Skills and Experience:
- Have 3-5 years of relevant experience in a regulated environment is required with Bachelor’s degree or higher in Engineering, Quality/Regulatory Affairs or a related discipline
- Experience in CMO plastics industry with international customers is preferred
- Quality Management System knowledge is preferred
- Relevant knowledge of GMP, ISO 13485, FDA 21CFR820, ISO 14971 or FMEA’s and other applicant standards
- Windows, Word, Excel, Access, Power Point, MS Project Experience in production creation/development and product industrialization is a pre
- Seen as respected authority/colleague in previous job
- English at Business and Technical Profiency at CEFR C1 level
- Have good written & oral communication skills and the ability to communicate appropriately with different engineering teams, Product Management, customers, vendors and partners
- Be able to travel occasionally to meet with customers / project teams
- Be able to work independently and as a member of a cross-functional team, to multi-task and do what it takes to meet high expectations and tight deadlines.
- Will be working on highly visible projects in high-pressure situations.
Are you interested in this position and based
in The Netherlands? Please send your CV and application to Heleen Stork, Corporate
Recruiter EU. E-mail: firstname.lastname@example.org