Overview
On Site
Full Time
Skills
Computerized System Validation
Computer Hardware
Programmable Logic Controller
Visual Basic
Database
Estimating
Document Management
VI
VMware Infrastructure
Change Request Management
Verification And Validation
Data Management
Project Management
Mentorship
Training
Policies and Procedures
Leadership
Management
Medical Devices
Writing
Documentation
Software Development Methodology
Interfaces
Attention To Detail
People Skills
Research and Development
Manufacturing
Auditing
Regulatory Compliance
Job Details
Responsibilities:
- 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, SCAD pplications, and systems with FDA defined electronic records and electronic signatures.
- Provide project estimates independently. Review estimates for Engineer I's.
- Submit specification, protocol and reports for approvals and documentation control vi Change Request.
- Develop comprehensive software validations and/or equipment qualification protocols per the specification.
- Execute software validation and/or qualification protocols & record results.
- Documents communicate and follow-up on software/equipment issues.
- Complete project deliverables per project schedule and monitor project schedule and scope changes to ensure that 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 a 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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