Location: Redwood City
Posted on: August 5, 2022
Be a part of a growing medical equipment manufacturing company
as a Quality Engineer!
This Jobot Job is hosted by Jake Benyshek
Are you a fit? Easy Apply now by clicking the "Apply" button and
sending us your resume.
Salary $100,000 - $130,000
A Bit About Us
We are a medical equipment manufacturing company. Our systems give
physicians a big opportunity with an exceptionally small, high
resolution, single-use advanced imaging system! It is ideal for a
multitude of current procedures as well as optically guided
injections, with numerous additional application possibilities in
Why join us?
If you want to be a part of the growth and success of an upcoming
medical equipment manufacturing company that is already making
waves in the industry with its innovative technology, this is the
place to be!
- 2-5+ years of experience as a Quality Engineer in the medical
- BA/BS degree in science, engineering or other technical
- Medical Device Quality System Knowledge Including 21 CFR Part
820 (QSR) & ISO 13485
- Strong computer skills (MS Suite, Data Entry, etc.)
- Experience participating in internal and external audits (e.g.,
FDA, Notified Body, Supplier)
- Experience with Design Control, CAPA, complaint investigation,
field action processes and risk management
- Performing root-cause investigations to establish corrective
action plans and implement corrective actions
- Developing and performing test methods for product testing and
- Collaborate with R&D on DHF and technical files to ensure
completion of design phases in a timely manner
- Collaborate with Regulatory to ensure compliance to FDA Quality
System Requirements (QSR) and ISO 13485 regulations and
- Develop and assist in the development of process
specifications, methods, validations, incoming inspections
- Develop quality related specifications and tests
- Develop and conduct V&V protocols as needed
- Collaborate with external test labs
- Prepare product and operations for design transfer
- Drive manufacturing and supplier controls
- Support NCMRs, CAPAs, and Complaints completion
- Support sterilization and packaging validation efforts
- Manage supplier control system
- Provide support for manufacturing by managing routine process
logistics and reviewing results.
- Provide support for environmental monitoring program and CER
- Track and report quality metrics
- Coordinate the documentation review, inspection workflow,
training, problem solving and calibration for products and test
- Performs standard quality engineering reviews of design
documentation for compliance with stated requirements, including
supplier quality and company quality records
- Works with manufacturing engineering to address supplier
Interested in hearing more? Easy Apply now by clicking the "Apply"
Keywords: Jobot, Redwood City , Quality Engineer, Engineering , Redwood City, California
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