2026/06/01 – 2026/12/01
Kravprofil
För kundsräkning söker vi nu en Chief design expert.
Execute and maintain Design Control documentation across assigned products including DCTM, DHF, Design Inputs/Outputs, specifications, manufacturing descriptions, and justification reports, ensuring version control and audit readiness.
Own and drive post‑approval change control execution, including impact assessments, documentation updates, and closure activities in alignment with approved Change Controls (CCs), deviations, and CAPAs.
Maintain and update Risk Management documentation (ISO 14971 aligned), including risk analyses, risk management reports, and updates linked to manufacturing changes, variations, and LCM activities.
Provide regulatory documentation support and review, ensuring consistency between design control files and regulatory submissions (EU MDR WW, US, CA), and supporting authority questions (e.g. MDR NB).
Support MDR EU and Worldwide projects execution by updating and approving MDR‑related design documentation (labeling reports, specifications, specification basis) and ensuring alignment to the EU MDR baseline.
Contribute design control and technical input to defined projects, including new syringe EU/US/CA submissions, new manufacturing line implementations, PPQ support, and packaging‑related design verification activities.
Establish and maintain Life‑Cycle Management (LCM) documentation packages, including initial MDR LCM sets and continuous updates based on manufacturing or supply changes.
Ensure specification robustness and justification, confirming that specifications are science‑based, properly justified, traceable to requirements, and suitable for regulatory and manufacturing use.
Uppdragsstart: 2026-06-01
Distansarbete: Nej
Uppdragslängd: 6 månader
Område: Sweden\Uppsala län,
Svar senast: 2026-05-25
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