Senior Test Method Validation

5 ore fa

Reggio Emilia, Emilia-Romagna, Italia Meet Life Sciences Ltd. Tempo pieno

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Meet Life Sciences is supporting a specialist Medical Device consultancy seeking a Senior Test Method Validation (TMV) Engineer for an immediate contract assignment in Italy.

Si assicuri di leggere l'intera descrizione riportata di seguito e di candidarsi immediatamente se è sicuro/a di soddisfare tutti i requisiti.

We are looking for an experienced engineer with extensive hands‑on expertise in TMV, Measurement System Analysis (MSA) and Gage R&R within a regulated manufacturing environment.

The successful candidate will independently lead test method validation activities, from protocol development and statistical analysis through to execution and final reporting.

Key responsibilities

Lead the development and execution of Test Method Validation protocols.
Conduct MSA, Gage R&R, repeatability and reproducibility studies.
Define acceptance criteria and evaluate test method performance using statistical analysis.
Analyse validation data using Minitab or equivalent software.
Prepare validation reports and technical documentation.
Collaborate with Engineering, Manufacturing and Quality teams to resolve validation challenges.
Ensure compliance with applicable medical device quality standards, including ISO 13485.
Extensive hands‑on TMV experience, ideally within Medical Devices.
Proven ability to independently plan, execute and interpret MSA and Gage R&R studies.
Strong statistical analysis skills, including Minitab or equivalent software.
Experience developing validation protocols, defining acceptance criteria and preparing technical reports.
Knowledge of ISO 13485 and regulated manufacturing environments.
Availability for a part‑time contract requiring on‑site support in Italy.

Location: Northern Italy - Hybrid, with on-site attendance required 3-4 days a month.

Duration: Initial 6 months. xysqume

Commitment: 20 hours per week.

Senior Test Method Validation

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