41 applicants
This job has closed.
DEKA Research & Development · 1 week ago
Quality Engineer
Manchester, NH
Full-time
Onsite
Mid Level
2+ years exp
Wonder how qualified you are to the job?
3D PrintingDeveloper Platform
Insider Connection @DEKA Research & Development
Responsibilities
Work cooperatively with cross-functional design team members and project management to ensure compliance with applicable SOPs and regulations.
Participate in and lead Risk Management activities in accordance with ISO 14971.
Develop, implement, and approve Hazard Analyses, FMEAs, and other Risk Analysis documentation.
Lead investigations, identify root causes, implement corrective actions, and verify effectiveness.
Coordinate investigations and provide guidance in Root Cause Analysis and CAPA.
Ensure compliance with applicable standards and regulations.
Document information accurately for communication with partners and regulatory bodies.
Prepare work plans and procedures such as Validation Plans.
Evaluate and approve proposed design or manufacturing process changes.
Drive system and process improvements.
Provide reliability and statistical analysis.
Participate in internal and external audits.
Qualification
Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.
Required
Bachelor’s degree in an engineering or related STEM discipline. Additional training and experience may be considered in lieu of degree.
Minimum 2-5 yrs. of experience as QE in a regulated manufacturing environment.
Preferred
Experience with compliance, with applicable standards and regulations such as 21 CFR 820, ISO 13485, and ISO 14971 is preferred.
Company
DEKA Research & Development
DEKA Research & Development provides technology solutions for power, mobility, and water applications along with fluid management.
501-1,000 employees
H1B Sponsorship
DEKA Research & Development 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
2023 (16)
2022 (16)
2021 (12)
2020 (14)
Funding
Current Stage
Late StageLeadership Team
Dean Kamen
Founder and CEO
C
Chris Langenfeld
Chief Engineer of Advanced R&D
Recent News
Medical Device Network
2024-05-21
Company data provided by crunchbase
