Quality Engineer II

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 the following: Quality System Documents, Product Documents, Test Methods, documents required for Design History File.
• Creates/reviews Protocols, Process and Product Validations, Stability Protocols
• Risk Assessments such as FMEA, FMECA or FTA.
• Provides work direction as required.
• 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

• The requirements listed in this section and below are representative of the knowledge, skill and/or ability required:
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Ability to perform detailed engineering work under direction of a Senior Engineer or Quality Management.
• May require consultation and direction to complete the key responsibilities.
• 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 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.
• Entry level position, experience with FDA regulated industry including experience with product development programs preferred

Mathematical Skills

• College level mathematical skills.
• Basic applied statistics.

Reasoning Ability

• Problems will be approached logically and methodically and be able to develop solutions and/or options.
• Judgment must be made by considering a few important facts.
• Written rules, precedents, and policies are available for guiding decisions, but are not always easily obtained.
• Decisions are made frequently, but are rarely needed immediately.
• As Design Control/ECR work and/or other responsibilities increase, so do the level of complexity and the importance of decision-making.

Physical Demands

• Employee may be required to sit, bend, stoop, use keyboard, see, talk and hear. May occasionally lift objects of 10 to 25 lbs.

Work Environment

• Office and manufacturing environments
• May include visits to clinical sites or hospitals.