DEKA Research & Development · 1 day ago
Quality Engineer - Failure Investigations
Manchester, NH
Full-time
Onsite
Mid, Senior Level
3+ years expDEKA Research & Development is focused on solving complex technical challenges, and they are seeking a Quality Engineer specialized in Failure Investigations. The role involves leading root cause investigations, driving product improvements through systematic analysis, and collaborating with cross-functional teams to ensure product safety and compliance.
3D PrintingDeveloper PlatformManufacturingMedical Device
Responsibilities
Lead and support field return investigations from initiation through closure, ensuring thorough root cause analysis and appropriate corrective actions
Participate actively in multidisciplinary investigation teams, bringing quality and regulatory perspective to technical discussions
Analyze field return data, failure modes, and trends to identify systemic issues and improvement opportunities
Interpret investigation results and translate findings into actionable recommendations for design, manufacturing, or process improvements
Ensure investigation findings are properly documented and integrated into the risk management file in accordance with ISO 14971:2019
Evaluate failure modes against existing risk analyses (FMEAs, Risk Analysis) and identify when risk file updates are warranted
Attain and maintain comprehensive understanding of device design, manufacturing processes, and core technologies to support effective investigation
Utilize structured problem-solving methodologies (e.g., 5 Whys, Ishikawa diagrams, Fault Tree Analysis) to systematically identify root causes
Review and approve investigation reports to ensure accuracy, completeness, and regulatory compliance
Provide guidance on QMS, FDA Part 820, and ISO 13485 compliance as it relates to investigations and corrective actions
Collaborate with design, manufacturing, and test teams to implement and verify corrective actions
Contribute to continuous improvement initiatives based on investigation insights
Qualification
Required
BS/MS in Science or Engineering
3-5 years' experience in quality engineering, failure analysis, or related role in a regulated environment
Demonstrated experience leading or supporting root cause investigations
Strong understanding of failure analysis methodologies and problem-solving tools
Knowledge of FDA's Quality System Regulation (21 CFR Part 820)
Knowledge of ISO 13485 and related quality standards
Experience with Risk Management principles (ISO 14971)
Experience with Corrective and Preventive Action (CAPA) processes
Strong data analysis and interpretation skills
Excellent written and verbal communication skills
Proficient in data analysis and documentation tools, including Excel, Word, Visio, and statistical analysis software
Preferred
Experience with medical device field returns and complaint handling
Knowledge of ISO 10993 (biocompatibility) and other product testing standards
Experience with Design for Reliability (DFR) principles
Familiarity with statistical analysis tools (Minitab, JMP, etc.)
Experience with electromechanical device development
Six Sigma or other formal problem-solving certification (Green Belt, Black Belt)
Experience interfacing with regulatory bodies or participating in audits
Company
DEKA Research & Development
DEKA Research & Development provides technology solutions for power, mobility, and water applications along with fluid management.
501-1000 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (13)
2023 (23)
2022 (16)
2021 (9)
2020 (7)
Funding
Current Stage
Late StageLeadership Team
C
Chris Langenfeld
Chief Engineer of Advanced R&D
Thomas Bollenbach
Project Manager
Recent News
2025-10-10
NH Business Review
2025-03-26
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