Quality Engineer Failure Investigations

Manchester, CT - USA

Monthly Salary: Not Disclosed

Posted on: 8 hours ago

Vacancies: 1 Vacancy

Job Summary

Join our dynamic team at DEKA and be at the forefront of solving complex technical challenges! As our Quality Engineer focused on Failure Investigations youll be a key player in our collaborative environment leading root cause investigations and driving product improvements through systematic analysis. Quality Engineering is a high-visibility role with a significant direct impact on the success of the project and the safety of our products. As a key contributor to our team the following skills are required:

Technical Expertise: Strong ability to comprehend complex electromechanical systems and apply engineering principles to failure analysis. Solid engineering foundation with practical problem-solving skills.
Investigative Mindset: Natural curiosity and systematic approach to uncovering root causes through data analysis inductive and deductive reasoning and structured problem-solving methodologies.
Risk Management Acumen: Understanding of how failure modes relate to product risks and ability to translate investigation findings into risk file updates.
Project Leadership: Skilled in managing investigation timelines coordinating with multiple stakeholders and driving investigations to closure with actionable outcomes.
Collaboration: Effectively lead cross-functional investigation teams facilitate discussions and build consensus around root cause and corrective actions. Foster a supportive and productive investigation environment.
Analytical Thinking: Ability to synthesize complex technical data identify patterns and draw sound conclusions from incomplete or ambiguous information.
Effective Communication: Ability to present investigation findings clearly and persuasively to diverse audiences from technicians to senior leadership adapting technical depth appropriately.
Self-Motivated: Able to independently manage multiple concurrent investigations prioritize effectively and maintain momentum without constant oversight.
Technical Writing: Proficient in documenting investigation reports root cause analyses and technical summaries with clarity precision and appropriate detail.

As a Quality Engineer you will contribute in the following areas:

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

Required Training / Knowledge:

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 FDAs 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.

Nice to have:

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

Required Experience:

Manager

Technical Expertise: Strong ability to comprehend complex electromechanical systems and apply engineering principles to failure analysis. Solid engineering foundation with practical problem-solving skills.
Investigative Mindset: Natural curiosity and systematic approach to uncovering root causes through data analysis inductive and deductive reasoning and structured problem-solving methodologies.
Risk Management Acumen: Understanding of how failure modes relate to product risks and ability to translate investigation findings into risk file updates.
Project Leadership: Skilled in managing investigation timelines coordinating with multiple stakeholders and driving investigations to closure with actionable outcomes.
Collaboration: Effectively lead cross-functional investigation teams facilitate discussions and build consensus around root cause and corrective actions. Foster a supportive and productive investigation environment.
Analytical Thinking: Ability to synthesize complex technical data identify patterns and draw sound conclusions from incomplete or ambiguous information.
Effective Communication: Ability to present investigation findings clearly and persuasively to diverse audiences from technicians to senior leadership adapting technical depth appropriately.
Self-Motivated: Able to independently manage multiple concurrent investigations prioritize effectively and maintain momentum without constant oversight.
Technical Writing: Proficient in documenting investigation reports root cause analyses and technical summaries with clarity precision and appropriate detail.

As a Quality Engineer you will contribute in the following areas:

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

Required Training / Knowledge:

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 FDAs 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.

Nice to have:

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

Required Experience:

Manager

Key Skills

APQP
Quality Assurance
Six Sigma
ISO 9001
PPAP
Minitab
Root cause Analysis
ISO 13485
Quality Systems
Quality Management
As9100
Manufacturing

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About Company

DEKA Research & Development

DEKA Research and Development is perhaps best known for its founder and president Dean Kamen -- and for the Segway Personal Transporter he invented. DEKA is a design and engineering firm that develops innovative technologies, many of them in the field of medical devices. The Segway it ... View more

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