Quality Engineer II

Posted 06 July 2021
SalaryUp to US$80000.00 per annum
LocationMableton, Cobb, Georgia
Job type Permanent
DisciplineEngineering
Reference19980
Contact NameDeLisa Chambers

Job description


Quality Engineer II
Claremont Consulting has an immediate direct hire need for a Quality Engineer II in the Smyrna, GA area. Candidate selected will primarily be responsible for activities that aid new product development/sourcing, product improvements, and product realization. This position will also be responsible for developing product specifications, risk analyses, and competitive product analyses.
Responsibilities:
  • Ensure implementation and rigor of product development processes and design control procedures in compliance with the QMS.
  • Support the design and development of medical devices and OTC drugs through all aspects of Design Control, specifically defining user requirements, V/V, and design transfer activities.
  • Manage supplier quality program, including but not limited to validation/verification review and executing supplier quality audits.
  • Problem solving of technical issues related to design, development, and manufacturing supporting complaint, CAPA and SCAR investigations.
  • Responsible for coordinating and managing project activities across all cross-functional team members to ensure timely completion of milestones.
  • Understand customer needs through literature review, customer interviews, direct observation, competitive analysis, prototype evaluation, and clinical/simulated use studies.
  • Develop, maintain, and review product specifications.
  • Manage process and equipment IQ/OQ/PQ functions in addition to reviewing IQ/OQ/PQs at contract manufacturers.
  • Engineering drawing review and maintenance.
  • Execute design validation/human factors/usability studies as needed.
  • Develop, maintain, and review DHFs and DMR's, as applicable.
  • Risk Management assessment and mitigation including DFMEA, UFMEA, and PFMEA.
  • Develop laboratory test procedures, perform and/or oversee test method validation and execution of testing.
  • Provide guidance on packaging technologies and sterilization processes.
  • Develop product labeling, ensuring product labels meet the US and international regulatory requirements and standards.

Education and/or Experience:
  • Bachelor's Degree in engineering discipline (Preferred: Chemical, Polymer, Biomed, Materials Science, Industrial, Mechanical).3+ years of progressively increasing Quality Engineering responsibility in a medical device or related industry/organization.

Preferred Education and/or Experience:
  • Certified Quality Engineer and/or Certified Reliability Engineer.
  • Lean Six Sigma Green Belt or Black Belt.
  • Terminal sterilization of medical devices knowledge (EO/Gamma/I-Beam), including validation processes.
  • Bilingual.

Skills and Knowledge Requirements:
  • Excellent working knowledge of 21 CFR 820.
  • Strong analytical, problem solving and technical writing skill.
  • The ability to work with a variety of disciplines and levels of staff both internally and externally.
  • Ability to work independently or as an integral part of a cross-functional team.
    • Able to understand, interpret, explain, and resolve technical issues.
    • Strong project management and organizational skills.
    • Experience with statistical analysis and associated software.