Do you have a Regulatory Affairs & Quality background? Modis Life Science is now looking for a Program Manager with experience from Quality & Regulatory Affairs for a 6 month consultant assignment starting the 29th of October in Lund. Welcome with you application no later than 17th of October. Selection takes place continuesly.
Consultant assignment QA R&D Lead
Modis is searching for a QA R&D Lead for a Monitor division with our client in Lund. You will be part of a great and skilled team that interacts with R&D department daily. We are looking for a team player that also can work independently. As part of QA R&D team, you are reporting to the QA R&D manager in the US. Tasks include the following:
- Coordinate QA activities in product development projects as Core Team member.
- Establishes and maintains Quality Plans in development projects to cover QA aspects related to product design, process/product development and quality metrics.
- Monitors and reviews timely and effective execution of the Quality plan including fulfillment of quality metrics.
- Evaluates CAPAs, NCRs production and post-production information from current products and ensures that this information is used as input to product development.
- Periodically reports to Manager QA R&D in Northern Illinois, USA on the status of activities under their responsibility.
- Participates in Design Reviews.
- Participates during audits/inspections.
- Reviews and approves Verification and Validation activities, including planning and protocols.
- Reviews and approves Design Review Reports
- Rejects and vetoes deliverables which are not adequate, nor based on objective evidence.
- Rejects and vetoes Design reviews, if needed.
- Fluent in Swedish and English, both written and spoken.
- Bachelor Degree or equivalent in science or engineering
- Quality Management education for Medical Devices is preferred
- Knowledge in quality engineering methods would be preferred e.g. Root Cause Analysis, Pareto, Ishikawa, Risk Management and more.
- Independent, solution oriented, analytical thinking.
- Good team player with ability to work as an independent person in a team or independently.
- Good Communication skills and ability to discuss with partners on a peer level
- Min. of 3 years´ experience in medical device industry, pharmaceutical industry and/or quality position is preferred
- Project leader experience is preferred
- Knowledge of appropriate regulations/standards for Medical Devices
Om Modis Life Science
Modis är ett globalt bolag som är specialister inom Life Science och ingår även i en av världens största HR-partner. Vi matchar rätt kompetens & rätt person till rätt uppdrag. Vi söker dig som är ingenjör, apotekare eller har erfarenhet av kvalitet inom farmakologi, medicinteknik eller bioteknik. Vi erbjuder konkurrenskraftig lön, upprätthåller en god kontakt och strävar alltid efter utveckling för våra konsulter.
Genom att bli vår kollega kommer din vardag som konsult vara varierad med uppdrag i olika projekt i diverse branscher, system och miljöer. Din erfarenhetsbank kommer att växa liksom ditt sociala och professionella kontaktnät. Som konsult omfattas du av kollektivavtal, försäkringar, företagshälsovård, friskvårdsbidrag och rabatter på träningskort. För att upprätthålla en god relation med konsulterna ordnar vi regelbundet med sociala aktiviteter som AW:n, luncher & andra evenemang.
Modis levererar en bred bas av tjänster och kompetenser inom IT, Engineering och Life Science. Våra tjänster präglas av enkelhet, kvalitet & professionalism. Modis finns representerade i USA, Kanada, Europa med över 100 kontor och med mer än 35 000 kollegor i uppdrag varje dag. Modis är ett bolag som ingår i The Adecco Group koncern där bland annat Adecco och Badenoch & Clark ingår.
Varmt välkommen med din ansökan!