Resonetics · 5 days ago
Quality Engineer
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Life ScienceManufacturing
Insider Connection @Resonetics
Responsibilities
Work with and lead cross functional teams utilizing the Product Development Process to ensure robust systems and controls are in place to produce defect free product while meeting business objectives and customer expectations.
Influence change and ensure understanding and compliance to 21CFR820, ISO 13485 and the Product Development process Drive and participate in Continuous improvement and Process validation activities using DOE's, FMEA's, Quality Plans, Gage R&R and other Quality tools
Work through unique and/or adverse situations, gather and review information from diverse functional areas, and make appropriate quality recommendations based on facts
Review and approve protocols, validation documents, investigations and procedure
Provides support by conducting investigations and assisting in data and information collection as required for quality events Interfaces as a subject matter expert with the FDA and other government agencies during site inspections.
Responsible for the development of process and quality procedures.
Implement Continuous improvement methodology and metrics in cell(s) to improve business metrics
Customer liaison for all quality related issues.
Mentor and train other engineers/technicians in quality methodologies and regulatory requirements.
Proactively develop improvement ideas based on experienced assessment of departmental and company performance Represent Quality in project team meetings and on assigned projects
Qualification
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Required
Minimum 10 years experience in a Quality Engineering role for a medical device manufacturer and/or start-up company
Demonstrated technical writing and communication skills
Working knowledge of Statistical software and/or Minitab
Bachelor's degree or equivalent experience
Company
Resonetics
Resonetics provides laser micromachining contract manufacturing solutions and systems for the life sciences and other high precision.
H1B Sponsorship
Resonetics 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
Trends of Total Sponsorships
2022 (1)
2021 (3)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
$1.12BKey Investors
The Carlyle GroupRegatta Medical
2021-12-03Private Equity· $1.12B
2018-02-01Private Equity· Undisclosed
2014-10-22Acquired· by Sverica Capital
Recent News
2023-10-02
Medical Product Outsourcing
2023-07-19
2023-06-12
Company data provided by crunchbase