Validation Engineer

embecta•Holdrege, NE

About The Position

The Site Validation Engineer is responsible for execution and implementation of validation initiatives in support of product design activities, maintenance of the site validation process, and cross-functional support for the Quality Engineering and Quality Systems group.

Requirements

Four-year college Bachelor of Science degree required.
Bachelor of Science degree in Engineering desired.
3+ Years Quality experience including Validation and Quality Engineering responsibilities.
Demonstrate success with statistical and problem-solving methodologies
Excellent knowledge of the principles for Quality Engineering and Quality management as related to validation process on medical devices
Strong understanding of failure analysis, test methods and engineering tolerances
Strong verbal, written and interpersonal skills
Proficient with Minitab or other statistical software, MS Word, Excel, and MS project
Project management experience

Nice To Haves

Six Sigma Certification Desired
American Society of Quality (ASQ) certificate for CQE Desired
Working knowledge of 21CFR820, ISO 13485

Responsibilities

Responsible for validation and GMP/Compliance Training within the plant in conjunction with the Quality Systems and Quality Engineering Leaders.
Develop and maintain the Validation Master Plan and validation tracking schedule.
Provide critical quality engineering direction with respect to generally accepted quality engineering tools/principles, such as root cause analysis, FMEAs, risk mitigation, validation, DOE/other process improvement tools, measurement and measurement systems analysis, sampling, and control plans.
Provide visibility related to all validation activities through tracking and reporting plant metrics.
Support and influence change management within the plant: liaison between the core team, program managers, and Global quality.
Conduct training relevant to validation process and procedures.
Approve protocols and reports for all validation and change control activities to ensure compliance to established procedures.
Utilize Lean and Six Sigma problem solving methods, data analysis tools and techniques to support department validation efforts around continuous improvement.
Lead and support quality engineering activities associated with change control, continuous improvement, and process optimization initiatives by ensuring appropriate risk assessments, validation requirements, product and process impact assessments, and effectiveness monitoring are completed in accordance with established quality system procedures.
Identify, prioritize, and support continuous improvement opportunities by analyzing quality, manufacturing, and customer feedback data to drive sustainable process and product improvements.
Provide leadership and function as a respondent during FDA, ISO, Corporate or other 3rd party audits.
Maintain alignment to company quality policies, procedures, and practices through consistent application of sound quality assurance principles. Make basic procedural updates.
Is an extended team member representing Site Quality on product development projects and a team member for sustaining engineering projects.
Establishes a strong working relationship with all levels of operations to appropriately monitor and analyze in-process inspection, process control activity, waste and reject rates, PM compliance, environmental control, and customer complaint levels to take a lead role in identifying and documenting continuous improvement projects.