Medical Device Software Validation

Boston, MA

Job ID: 124618 Industry: Med

 

Medical Device Software Validation

Environment:
Our client is a large manufacturer of class II and III medical devices.

Responsibilities:

Our client is looking for a software validation consultant to support their Global Quality System. This will include writing and executing IQ/OQ/PQ’ s as well as performing risk assessments and validation assessments for computer system changes across multiple facilities.   Duties include, but are not limited to, oversight, review, and approval of validation-related documents, participating in risk assessments to determine which elements should be validated, and conducting validation impact assessments of proposed changes to computer systems. This position may interact with regulatory agencies and corporate partners during inspections and audits. Someone with a background in project management and compliance would be a plus.They NEED to have experience with Agile Document Management or Doc-ER experience.

Want someone with working experience of regulations relating to medical device products and software (e.g. 21CFR Part820, 21CFR Part 11, EN ISO 13485, IEC 60601, EN ISO 14971: 2012, IEC 62304, FDA’ s General Principles of Software Validation).

Required:

Medical Device

Software Validation

Risk management

Agile Document Management or Doc-ER experience

 

Plus:

Project Management

Compliance

Job Type: Contract 

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