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QA Validation Manager Combination Products (m/f)

Eingestellt von Hays aus Mannheim, Universitätsstadt

Gesuchte Skills: Design, Engineering

Projektbeschreibung

REFERENZNUMMER:

316981/11

IHRE AUFGABEN:

-Serve as the subject matter expert for design transfer, process validation and pFMEA requirements according to 21CFR Part 4 of allocated medical devices/combination products
-Serve as the quality subject matter expert for allocated device development projects and ensure all projects follow the applicable risk management procedures (especially for process FMEA), relevant design control activities, and prepare control strategy definition
-Collaborate with all QA representatives (Device Quality, Clinical Quality, Manufacturing QA, QA validation at the manufacturing site) to ensure robust process validations are in place
-Actively participate up to facilitating process FMEAs, and ensure all necessary GMP documentation are completed and in place for combination products at the manufacturing internal site or Device CMO

IHRE QUALIFIKATIONEN:

-BS degree in a Life Sciences discipline or chemical/mechanical engineering, graduate degree preferred
-Hands-on expertise in process validation for combination products preferred
-Understanding of the biotechnology industry and specifically combination products and experience in working in a global environment preferred
-Demonstrated problem solving and decision making skills, including hands-on working experience with Six Sigma/DMAIC
-Sound knowledge of quality systems regulations, and medical device directives, ISO 13485:2003 and ISO 14971 as well as 21 Part 210/211
-Honed teamwork and collaboration skills and ability to communicate clearly and professionally both verbally and in writing

WEITERE QUALIFIKATIONEN:

Quality manager, Qualification/validation specialist

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    12 MM++

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Hays

  • Straße:

    Willy-Brandt-Platz 1-3

  • Ort:

    68161 Mannheim, Universitätsstadt, Deutschland