Description:

Validation Engineer

SUMMARY:

This document outlines the employment prerequisites and job responsibilities for the position of Principal Engineer, Quality Validation.

ESSENTIAL FUNCTIONS:

The person in this role has primary responsibility for driving overall quality performance, improvement, and compliance throughout the organization.

Provide metric reports to management during management reviews and reports.

Implement quality programs and establish quality assurance measures at all key stages of manufacturing.

Review of manufacturing, purchasing and test documentation to ensure requirements are fulfilled.

Review drawings, specifications, procedures, test procedures, inspection and test analysis.

Develop procedures for production testing and standardize inspection methods.

Promote and train personnel to ensure awareness of regulatory and customer requirements throughout the company.

Act as a technical team leader including training and developing less senior staff on the team.

Support operations with quality issues/root cause analysis/corrective actions.

Support the Quality Management System

Lead the development and execution of engineering studies, quality plans, validation packages, and

Lead the development and execution of IQ, OQ and PQ protocols for product, processes and equipment within the facility.

Write reports summarizing results and statistics for all equipment, product, or process validation projects.

Trend and report on the Manufacturing NCRs – including process effectiveness and corrective and preventative actions and make recommendations for improvements.

Develop and communicates expectations for quality performance, continuous improvement, quality systems, process controls infrastructure for critical sustaining parts and new products.

Participate as an active member in the new products development team.

Monitor and drive corrective action and continuous improvement activities that directly impact performance measures.

Conduct or lead corrective and preventive actions in manufacturing using formal problem solving tools and documentation.

Provide day-to-day support to engineering and manufacturing in implementing process improvement.

Assist or lead process improvement projects (scrap reduction, defect reduction, etc.)

Be able to assist, present, defend and communicate with internal and external auditors.

Perform other duties as assigned

QUALIFICATIONS, KNOWLEDGE, AND SKILLS REQUIRED

Experience in the medical device industry in development and deployment of Quality Systems, implementing process controls, and continuous improvement methodologies

Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC; CMDAS requirements.

Knowledge and working application of validation principles and guidelines and industry practice.

Knowledge and working application of PFMEA and Risk Analysis.

Knowledge and working application of reading and understanding blue prints and technical drawings.

Knowledge and working application of standard operating procedures.

Display a solid technical understanding of engineering principles and procedures (e.g. CAD and its application or scheduling a series of technical tasks utilizing software-based tools.

Understand and articulate how own role ties within function or discipline

Demonstration application of engineering principles on individual/small projects

Demonstrated strong analytical problem solving (CAPA), teaming and communications/interpersonal.

Desired CQE, CSSBB, CQA or initiative to complete certifications.

Prefer experience with TQM methods (e.g. "six sigma").

Internal Quality System auditing experience (ISO 13485 and FDA 21CFR820).

Computer competency in Word, Excel, Power Point, Minitab, Access and databases.

Ability to multi-task and methodically manage projects.

Ability to work independently and in team environments.

EDUCATION/EXPERIENCE REQUIRED

Bachelor’s degree in Engineering

5-8 years of related experience

Six Sigma Certification (Green Belt or Black Belt) is desirable

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee:

Ability to stand or walk for long periods,

lift and carry at least 20 pounds, perform repetitive motions with hands/fingers.

Must have good hand to eye coordination and dexterity

VI. WORK ENVIRONMENT

Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Wear a static protective smock at all times while in the manufacturing work area.

Work in close proximity to other employees.

Work in an environment that is temperature and humidity controlled.

Note:

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