What are the responsibilities and job description for the Quality Engineer II position at MillenniumSoft Inc?
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
The requirements listed in this section and below are representative of the knowledge, skill and/or ability required:
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.
- 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.
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.
- 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
- College level mathematical skills.
- Basic applied statistics.
- 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.
- Employee may be required to sit, bend, stoop, use keyboard, see, talk and hear. May occasionally lift objects of 10 to 25 lbs.
- Office and manufacturing environments
- May include visits to clinical sites or hospitals.
