Quality Project Engineer
il y a 6 jours
Lead management of material, process and product quality attributes according to quality standards - from functional analysis based on product URS, through design and process FMEAs (risk assessment), up to completion of process and product qualifications
**Main Responsibilities & Tasks**:
- Lead management of material, process and product quality attributes according to quality standards - from functional analysis based on product URS, through design and process FMEAs (risk assessment), up to completion of process and product qualifications
- Ensure full continuity between functional analysis, FMEAs, list of critical and significant material, product and process attributes, product specifications incl. drawings, control plan, work and inspection instructions in assigned project
- Participate actively to or facilitate Design and Process FMEAs
- Actively participate to definition and review of product specifications for raw materials and components
- Specify, monitor manufacturing and approve gauges, checking and measurement equipment
- Participate actively to definition and review of qualification and validation protocols - CSV, Product, Process, Components/Sub-systems - ensure data driven validations and qualifications and monitor progress
- Oversee, alert if required and actively participate to investigation according to 8D principles for all critical and major deviations related to product and process qualifications and to product compliance.
- Create and maintain Prototype, Pre-Series and Series Control Plan until handover to Site Quality incl. Interco Site Quality
- Define inspection instructions for in-process control and for finished product incl. boundary samples and handbooks. Participate to operators/inspectors’ training plan definition
- Plan, supervise, improve and approve all relevant Measurement System Analysis - for visual inspections and measurements
- Review and approve Process Capability Studies
- Where required, participate actively to definition of robust containment actions and CAPA definition to close gaps and secure launch
**Qualifications & Skills**:
- Master degree in Engineering or biotechnology
- Min. 5 years’ experience in production or in engineering center - industries targeted biotech, automotive, pharma.
- GMP knowledge or Medical device knowledge / ISO13485
- Project management experience in Medical device or biopharma: implement, master and track timing plan, key performance indicators and action plan.
- Strong FMEA / risk assessment knowledge
- Strong problem solving methodologies knowledge - e.g. 8D, QRQC
- Basics in statistics (normal distribution, process capabilities, MSA, SPC)
- English fluent
- Leadership, accountability, team work and assertiveness
We look for employees who would like to grow with us and move the innovative life sciences sector forward. In the process, we focus on agile project work, mutual support within teams and working as equals. Sartorius thrives as a company with people who give their very best every day and who are eager to develop personally and professionally.
Further insights into our world of work can be found here.
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