Product Quality Engineer – Medical Devices Job at Datamatics Global Services Inc
Position: Sr. Product Quality Engineer – Medical Devices
Location: Alameda, CA 94502
Duration: 12+ months
Job Description:
- Bachelor’s degree in Science, Engineering or a closely related discipline. With Minimum 5 years of relevant working experience.
- Six Sigma Black Belt (CSSBB) or ASQ Certified Quality Engineer (CQE) is highly desired
- Engineering experience and demonstrated use of Quality tools/methodologies
- Knowledge of FDA, GMP, ISO 13485, and ISO 14971.
- Solid communication and interpersonal skills
- Strong project management and leadership skills
- Advanced computer skills, including statistical/data analysis and report writing skills is a plus
- Medical Devices/Diagnostics and/or other regulated healthcare industry experience is required
- Experience implementing various product and process improvement methodologies (e.g., Value Stream Mapping, Six-Sigma (DMAIC), Lean, Kaizen)
- Experience working in a broader enterprise/cross-division business unit model preferred.
- 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.
- Demonstrates analytical capability to find systemic issues to root cause, and create actions plans to mitigate, close and/or eliminate.
- Knowledge in software and hardware development life cycle…
Job Types: Full-time, Contract
Salary: $60.00 - $66.00 per hour
Schedule:
- 8 hour shift
Education:
- Bachelor's (Required)
Experience:
- Product Quality Engineer: 7 years (Required)
- FDA, GMP, ISO 13485, and ISO 14971: 4 years (Required)
- Medical Devices/Diagnostics and/or healthcare industry: 4 years (Required)
Work Location: One location
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