Job Description
Job DescriptionQuality Validation EngineerPosition Summary: The Quality Validation Engineer ensures product quality and process control throughout design and manufacturing. This role supports compliance with ISO 13485 and FDA 21 CFR regulations, helps improve quality systems, and provides technical quality support to R&D and manufacturing teams. Responsibilities include participating in new product development, creating validation plans, developing test methods, and executing validation protocols (IQ/OQ/PQ). The engineer also prepares documentation, leads validation efforts, and coordinates with teams to ensure timely and compliant execution across all phases of the process.Responsibilities:
- Apply statistical tools to determine test sample sizes and validate test methods
- Lead FMEA risk analysis sessions (design/process) and document findings and actions
- Investigate material failures to identify root causes and implement corrective actions
- Support new product transfers, including equipment and process qualifications and validations
- Review and approve design and process documentation changes
- Assist in developing and validating test methods with the R&D team
- Participate in internal quality audits
- Help develop and maintain quality systems in compliance with ISO standards
- Review and approve incoming inspection plans and sampling strategies; enhance QC methods as needed
- Support quality control tasks including testing, inspections, and product release when required
- Contribute to the implementation of the company’s validation strategy
- Ensure validation activities follow internal policies and procedures
- Prepare, distribute, and manage validation protocols and final reports
- Execute validation phases and coordinate support to ensure protocol compliance
- Document and report any protocol deviations
- Coordinate with planning, scheduling, and sales to maintain effective communication and documentation
- Provide project updates and feedback on validation activities to relevant teams
- Collaborate and share insights with the process engineering team
- Follow all safety policies and procedures in daily work
- Understand and apply all relevant quality management system requirements, including the Quality Policy and job-specific procedures, and recognize how individual performance contributes to broader company goals
Requirements:
- Bachelor of Science or related discipline
- Have an understanding of quality.
- Must have validation experience.
- Be able to work independently- 1 person role.
- Understand capability process. Ranges and out of validation.
- Communication- Verbal & Written protocol develop.
- Experience and Knowledge in Good Manufacturing Practices (GMPs) and Quality Systems and ISO-13485.
- Strong customer focus.
- Excellent communication skills
- Propose innovative practices to ensure processes are efficiently validated and product could be available for sale to the appropriate market.
- Experience with medical instrumentation and disposables, in a regulatory environment (i.e. GMPs, ISO9001, ISO13485, etc.).
- Proficient in knowledge of variety of testing equipment (including Introns, pin gages, snap gages, micrometer, caliper, etc.).
- Proficient technical writing skills and use of documentation programs (e.g. Office Windows, Excel, Access, Power Point, etc.).
- Working knowledge of fundamental quality and statistical tools including SPC, DOE, Six Sigma.
- ASQ Certified Quality Engineer Preferred.
Salary: $75k + DOE