Quality Engineer

4 months ago

Covington, United States MILLENNIUMSOFT Full time

Job Title: Quality Engineer

Location: Covington, GA

Contract Term: 3+ Months

Weekly 40.00 Hours [Mon - Fri]

1st Shift

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 include the following. Other duties may be assigned.

• 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
To perform this job successful, an individual must be able to perform each essential duty satisfactorily. 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 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.

Language Skills
Ability to read and comprehend verbal and written instructions. Ability to effectively present information in one-on-one and group situations to supervisor, management and other employees of the organization.

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

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

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