What are the responsibilities and job description for the Quality Engineer - Medical device position at TekOne IT Services Pvt. Ltd.?
Role: Quality Engineer - Medical Device
Location: Santa Clara, CA
Duration: 12 Months on W2
Job Description
Required Skills
Location: Santa Clara, CA
Duration: 12 Months on W2
Job Description
Required Skills
- BS degree in Engineering or Technical Field or equivalent experience; 2-5 years’ experience
- Engineering experience and demonstrated use of Quality tools/methodologies
- Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
- Solid communication and interpersonal skills
- Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
- Advanced computer skills, including statistical/data analysis and report writing skills
- Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
- Ability to work in a highly matrixed and geographically diverse business environment
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Ability to leverage and/or engage others to accomplish projects
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
- Multitasks, prioritizes and meets deadlines in timely manner
- Strong organizational and follow-up skills, as well as attention to detail
- Ability to travel approximately 0 - 10%
- Ability to maintain regular and predictable attendance
- Advanced degree preferred
- ASQ CQE or other certifications preferred
- Prior medical device experience preferred
- Experience in catheter product preferred
- Experience working in a broader enterprise/cross-division business unit model preferred
