101 applicants
DEKA Research & Development · 1 week ago
Quality Engineer
Manchester, NH
Full-time
Onsite
Mid Level
2+ years exp
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Responsibilities
Work cooperatively with cross functional design team members and project management to determine the best approach for on-going compliance with applicable SOPs and regulations, such as 21 CFR 820 and ISO 13485
Participate in and lead Risk Management activities in accordance with ISO 14971
Lead investigations including root cause identification, corrective actions, and verification of effectiveness, through use of data analysis, inductive and deductive reasoning, and problem solving skills
Coordinate the efforts of individuals and teams performing investigations
Use experience within manufacturing and monitoring of medical devices, to provide guidance in Root Cause Analysis and CAPA
Use experience with engineering and technology to identify and ensure compliance with applicable standards and regulations
Ensure the accurate documentation / recording of information to be used in communication with partners and regulatory bodies
Prepare detailed work plans and procedures such as Validation Plans
Evaluate and approve proposed design or manufacturing process change
Drive system and process improvements
Provide reliability and statistical analysis
Participate in internal and external audits
Qualification
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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.
Experience with compliance, with applicable standards and regulations such as 21 CFR 820, ISO 13485, and ISO 14971 is preferred.
Ability to:
Multitask and carry tasks through to completion
Manage multiple sources of data and develop reports
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
