Sr. Quality Engineer

Job Summary

This position performs various quality-engineering functions and associated support tasks in developing knowledge and experience in the areas of Quality Assurance/Document Control/Design Control. This includes working to support Design Control projects as well as other duties in support of the Quality System, Design Control System, Document Control, Manufacturing, and the R&D/Product Development departments.

Essential Duties and Responsibilities

• Represents the Corporation, Division and Quality Department in a professional manner.
• Participates on Project Team as Quality Representative. Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development.
• Provides support for Project Teams or Quality Department as required such as generating RFS, ECR, PQR, etc. as required.
• Creates and reviews Quality System Documents
• Creates and reviews Product Documents
• Creates and reviews Test Methods
• Creates/reviews Protocols, Process and Product Validations, Stability Protocols
• Provides work direction as required.
• Creates and reviews documents required for Design History File.
• Creates and reviews Risk Assessments such as FMEA, FMECA or FTA.
• Performs Internal or Supplier Quality System Audits.
• Ensures compliance to Department and Division procedures.
• Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner.
• Interfaces with manufacturing facility or other Division Facilities.
• Travels as required by the above duties and responsibilities.

Qualifications

• Ability to perform detailed engineering work under direction of a Senior Engineer or Quality Management. May require consultation and direction to complete the essential duties and responsibilities.
• Understands basic applied statistics.
• Knowledge of manufacturing processes
• Comprehensive knowledge of quality systems and relationship to business.
• Experience in writing process, software, and equipment protocols/validations and has fundamental knowledge of validation principles.
• Ability to participate on teams and maintain positive work environment with those teams.
• Good communication skills (verbal, written, and presentation)
• Understands Basic Fundamentals of Engineering Principles
• Ability to effectively manage time
• Ability to handle multiple task assignments.
• Ability to translate quality requirements into product specifications.
• Ability to interpret Regulations, Corporate, Division and Department Procedures.

Education and/or Experience

• B.S. in Engineering, Engineering Technology, Science a minimum.
• American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred
• Minimum 3 years of experience with FDA regulated industry, preferably on product development programs.