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.
- 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.
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.