Quality Engineer

NeuSpera Medical is seeking a Quality Engineer to support to R&D, product development and manufacturing, as well as external suppliers. Key areas of support include risk management/communication, verification/validation activities, inspection technique support, non-conformance and defect resolution, process capability/process improvement, verify, CAPA and change management. This position is expected to take a hands-on approach on all aspects of quality engineering and quality systems.

Location: NeuSpera Medical, Inc. headquarters in San Jose, CA

Reporting to: Senior Director of Quality

Base Pay: Negotiable
Employment Type: Full-Time
Job Type: Administration
Education: 4 Year Degree
Experience: At least 5 years
Manages Others: Yes
Industry: Medical Devices
Required Travel: Occasional

JOB DUTIES:

  • Develop and implement product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses, and FMEAs to provide a high degree of assurance that specific design and processes will consistently and continually produce a product that meets specifications and critical to quality attributes
  • Support design, test, and inspection method development, and lead method validation activities
  • Support manufacturing process development & qualification for new product commercialization and product changes
  • Lead supplier development activities by conducting reviews and visiting supplier sites, assessing suppliers’ technical competency and compliance to requirements, and developing and implementing improvements/modes of control within the supplier processes to minimize non-conformances
  • Manage Receiving Inspection and provide engineering support to Receiving Inspection by ensuring objective component specification definitions, supplied component sampling plan development, and vendor qualifications
  • Perform internal and supplier Quality System audits and CAPAs to ensure compliance with Quality System elements and determine root cause and corrective actions as needed
  • Provide guidance on data analysis and statistical tools to conduct or support of trend analysis, root cause analysis, failure investigation, and risk assessment
  • Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which NeuSpera complies
  • Must be a creative problem solver, quick with ideas, results oriented; and have strong communication skills
  • Other responsibilities as assigned

JOB REQUIREMENTS

Qualifications and Experience:

  • B.S. in an Engineering discipline
  • 5 or more years of operations experience, preferably in quality roles at Medical Device start-up companies
  • Experience in interfacing with internal Development and Operations teams and with External partners
  • Demonstrated increasing job responsibility over the progression of career
  • Results driven, collaborative team player capable of working well with others, as well as autonomously with little direction
  • Ability to adapt to dynamic situations and adjust as we grow
  • Breadth of knowledge over engineering and manufacturing disciplines
  • Experience with active implantable medical devices
  • Experience with hermetic laser welding and feedthrough assemblies desired.
  • Basic understanding of electrical and software engineering

Work Environment:

  • Office and Laboratory
  • Some travel necessary

Apply Now

Apply by email: careers@neuspera.com


1 comment (Add your own)

1. Rohan Nadkar wrote:
I have applied to this position through the neuspera career email. I look forward to hearing from NeuSpera.

Mon, August 13, 2018 @ 2:44 PM

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