MillenniumSoft Inc

Quality Engineer (Exp in Medical Device/Healthcare/Product Development/Pharma) Onsite

MillenniumSoft Inc Covington, GA
MillenniumSoft Inc

Quality Engineer (Exp in Medical Device/Healthcare/Product Development/Pharma) Onsite

MillenniumSoft Inc Covington, GA
6 months ago 53 applicants

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Position : Quality Engineer (Exp in Medical Device/Healthcare/Product Development/Pharma)

Location : Covington, GA

Duration : 6 Months

Total Hours/week : 40.00

1st Shift

Client : Medical Devices Company

Job Category : Engineering

Level of Experience : Senior Level

Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)7

8am - 5pm EST (1st shift)

Hybrid - must be local 4 days onsite and 1 day remote

Job Description

  • 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.

  • Seniority level

    Entry level

  • Employment type

    Contract

  • Job function

    Quality Assurance

  • Industries

    Staffing and Recruiting

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