Job Description

• To ensure the quality of our client's software applications and equipment by validating/qualifying to specifications.
• Provide comprehensive documentation (specifications and validation/qualifications) per the division's policy to meet FDA regulations.

• Define the development of comprehensive specifications (hardware and/or software) for equipment/software from basic functionality to complex systems such as PLC's, Visual Basic applications, databases, SCADA applications, and systems with FDA defined electronic records and electronic signatures.
• Provide project estimates independently. Review estimates for Engineer I's.
• Submit specification, protocol and report for approvals and documentation control via a Change Request.
• Develop comprehensive software validations and/or equipment qualification protocols per the specification.
• Execute software validation and/or qualification protocols & record results.
• Document communicate and follow-up on software/equipment issues.
• Complete project deliverables per project schedule and monitor project schedule and scope changes to assure team can meet delivery requirements.
• Create documents, links and Change Requests utilizing a Product Data Management system.
• Provide information on FDA/QSR regulations and internal process validation policy with regards to software validations, equipment installation qualifications, electronic records & signatures.
• Develop and review comprehensive validation procedures in compliance with FDA.
• Perform project lead activities on small to large-scale validation/qualification projects. Participate in vendor evaluations.
• Provide guidance, mentoring and training to Engineer I's & II's. Ensure consistency of work among Engineer I's & II's. Provide peer reviews on specifications, protocols and reports.
• Influences and defines functional, departmental and divisional policies & procedures through involvement with cross-functional engineering initiatives.
• Provide leadership role on championing functional best practices.

• Bachelor's Degree in Engineering Discipline
• 5-9 years direct experience
• Experience in Medical Device manufacturing specifically writing compliance documentation
• In depth knowledge of MS Office tools
• Must have excellent organization, clear verbal and written skills
• Experience working in a SDLC-system development lifecycle
• Hand on skills using navigating equipment user interfaces
• High level attention to detail and ability to support multiple priorities at once
• Must be team-oriented with people skills and positive can-do attitude in dealing with many customers, from various departments (Engineering, R&D, Manufacturing, Regulatory, etc.)

• Experience working in FDA-regulated industry
• Experience working with a regulatory body in an audit
• Performed in a quality role ensuring industry compliance
• Practical knowledge of 21 CFR Part 11 (electronic records/electronic signature)

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