Job Description
Your Profile
Job Requirements:
• Bachelor’s degree in engineering field or related field. Master’s degree in engineering is preferred.
• 3-7 years of experience in high volume regulated manufacturing industry in engineering field.
• Working experience of Six Sigma, lean and Quality Management Tools
• A broad knowledge of theory and principles of statistics and statistical process control
• Experience with Access Database, Excel and complaint handling software.
• In-depth knowledge of ISO13485, ISO14971, CFR part 820.
• Good understanding of medical device regulation, industry, and international standards.
• Strong computer skills in MS Office
• Ability to recognize and projects
• Ability to read and understand technical drawings and documents
• Working experience on CAD/SolidWorks
• Ability to work independently and take initiative
• Excellent communication, analytical, trouble-shooting and interpersonal skills
• ASQ Lead Auditor or equivalent training in auditing
• A team player as well as the ability to work independently
Physical Requirements:
• Must be able to work overtime as needed
• Must be able to sit, stand and walk for up to 8 hours
• Must be able to lift up to 70 lbs