Must Have: Minimum Requirements
Bachelor’s degree in Engineering, Science or Technical field with 4+ years of work experience in engineering and/or quality OR a Master’s degree in Engineering, Science or Technical field and 2+ years of work experience in engineering and/or quality.
Nice to Have
- Experience working in the medical device, biotechnology, automotive, aerospace or pharmaceutical industry
- Experience with Process Validations and/or Test Method Validations (For Example: IQ, OQ, PQ, and/or TMV)
- Prior experience with electrical, chemical, plastics, mechanical, and/or electro-mechanical commodities
- 5+ years of directly relevant experience in a Supplier Quality Engineering role
- Advanced degree (MS and/or MBA), Master’s degree in Engineering or Scientific field with an emphasis in Engineering, Materials, Quality Assurance, or Quality Systems
- ISO 13485 Lead Auditor Certification
- Experience with polymers, plastics and injection molding is highly desirable - Knowledge with PPAP/high volume process and part validation techniques
- Knowledge of the Medical Device regulations (21 CFR 820 and ISO 13485) - ASQ certified quality engineer (CQE) and/or black belt certification
- Ability to work with minor guidance and under pressure - Ability to drive and deliver innovative, effective and timely solutions as well as mentor others in best practices and industry standards where applicable
- Low Cost Country/Asia/Europe experience combined with high tech/med-high volume processes
- Effective verbal and written communication skills in order to effectively communicate with internal customers and suppliers, and to develop and present communication plans and strategies. Must be a team player.