Max bill $80
8am 5pm EST (1st shift)
Hybrid - must be local 4 days onsite and 1 day remote
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 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.