Endotronix · 5 hours ago
Senior Quality Engineer - Reader
Naperville, IL
Full-time
Remote
Senior Level
$93K/yr - $114K/yr
5+ years exp
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Responsibilities
Develop a thorough understanding of the entire product lifecycle for Endotronix product
Provide quality engineering input to establishment of product specifications, quality plans, and manufacturing procedures which consider risk management
Review and approve design verification and validation protocols and reports to ensure that test article selection, sampling rationales and test methodologies are technically sound and sufficient given level of risk and internal/external requirements.
Review risk analyses and design and usability FMEAs for adherence to requirements
Participate in design reviews to ensure customer and regulatory requirements have been properly translated into design inputs which are complete, unambiguous and do not conflict.
Encourage continuous improvement in design control activities and proactive utilization of quality tools with design team.
Support design for manufacturing in the design phase through design transfer to manufacturing, both internally and externally
Support manufacturing process optimization to encourage reproducible quality outcomes
Assist with management and monitoring of process control metrics in manufacturing environment.
Develop sampling plans for quality assurance based on product risk and supplier performance
Perform root cause analysis of field, incoming, and manufacturing issues and implement corrective actions.
Apply learned techniques and contribute to analysis and investigation to solve problems
Support suppliers and internal investigations on quality related issues and returned material analyses.
Model a culture of quality within the company and guide employees in best quality practices.
Build and enhance productive internal and external working relationships to resolve mutual problems by collaborating on procedures or transactions.
Qualification
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Required
5+ years' experience in quality engineering role and/or 3+ years' experience with an advanced degree
Experience with quality principles and tools
Capability in application of statistical techniques and sampling plans
Skills in root cause analysis and determination of appropriate corrective action
Working knowledge of IS013485 and IS014971 requirements
Strong organizational skills
Proven ability to work independently and in a collaborative team environment
Preferred
Experience in both design and manufacturing environments
Experience in medical device industry, preferably with electromechanical devices and medical device software
ASQ Certified Quality Engineer
Technical writing skills, experience creating SOPs in a Quality Management System
Company
Endotronix
Endotronix is a developer of hemodynamic monitoring technologies to help detect worsening heart failure earlier than ever before.
51-200 employees
H1B Sponsorship
Endotronix has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (2)
2022 (1)
2021 (2)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
$129.6MKey Investors
EQT Life SciencesSilicon Valley Bank
2024-07-24Acquired· undefined
2018-09-14Series D· $70M
2017-01-12Debt Financing· $12M
Leadership Team
Harry D. Rowland
Chief Executive Officer and Co-Founder
Anthony I. Nunez
Co-Founder
Recent News
2024-05-19
2024-04-14
Company data provided by crunchbase
