A bit about us:
We have an outstanding career opportunity for a Quality Validation Engineer with health care or medical device manufacturing experience to join a growing, global Medical Device Manufacturer located in the beautiful St. Louis, MO. area.
The QC Validation Engineer is responsible for the coordination and documentation of validation efforts with other departments providing validation guidance to all levels for quality assurance, compliance, and continuous quality improvement.
The position ensures products are developed, manufactured, tested, and delivered according to established procedures that will assure they meet all validation requirements.
The position develops and executes equipment, material, cleaning, and process validation protocols including statistical analysis of data generated by validation studies.Why join us?
We offer an industry wide and area competitive compensation plan including an amazing and extremely comprehensive benefits package.
Relocation assistance is available.Job Details
- Coordinate and document validation efforts with other work groups including Engineering, QC, and R&D, acting as the primary validation interface between Engineering and QA.
- Develop and execute equipment, material, cleaning, and process validation protocols including statistical analysis of data generated by validation studies and compiling relevant documentation.
- Assure validation documentation is generated, reviewed and approved in accordance to procedures.
- Contribute as validation subject matter expert by sharing technical expertise across departments, mentoring individuals to ensure knowledge consistency, and providing primary validation support to audits.
- Identify, evaluate, and manage risk by utilizing techniques such as FMEA, Fault Tree Analysis, Fishbone Diagram, HACCP, etc.
- Integrate risk based decision making with the validation life-cycle.
- Support Change Control Processes through assessment of system changes, and execution of re-validation and/or re-qualification activities as needed.
- Ensure validated state is maintained by performing periodic review of equipment, processes, etc.
- Review and approve engineering specification documents.
- 7+ years of experience performing primary duties in health care or a related regulated industry.
- Bachelors Degree in Engineering or Life Science.
- 5+ years of experience if you have earned your Masters Degree.
- Must have knowledge of ISO 13485 and FDA validation requirements including knowledge of FDA 21 CFR Part 820.
- Knowledge of 21CFR Part 11 is a plus.
- Must possess strong understanding of cGMPs and validation / qualification concepts.
- Requires effective written and oral communication skills to interact across all levels of the organization.
- Requires expert skills in risk analysis, problem solving, statistical methods, and detail oriented technical writing.