Senior Quality Engineer
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Must Have:
- Bachelors or masters degree in Engineering with overall 8 to 12 years of experience in supplier quality & DHF remediation is recommended
- Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
- Good verbal and written communication skills including protocol / report development and technical presentations
- Knowledge of Risk Management standard - ISO 14971
- Ability to comprehend principles of engineering, physiology and medical device use
- Previous customer-facing and/or project management experience is a plus
- Previous experience working with global team
- Comfortable working with international and multi-cultural department and groups in different time zones .
- Good understanding of problem solving , MSA ,Control plans,Quality tools and methodologies
- Accurate and delivers quality work, with a sense of urgency
- Strong communication skills, both oral and written
- Good interpersonal skills
- Ability to work in a fast-paced environment
- Ability to work well under pressure and maintain positive, enthusiastic attitude
- Eagerness to learn and expand responsibilities
- Ability to work effectively in a team environment and build strong working relationships.
- ASQ Quality certification
- Working knowledge of Standard, Guidance, and Regulations
- Hand on experience on Minitab tools
