Quality Engineer - Failure Investigations at DEKA Research & Development

Manchester, New Hampshire, United States -

Full Time

Start Date

Immediate

Expiry Date

26 Jun, 26

Salary

0.0

Posted On

28 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Failure Investigations, Root Cause Analysis, Electromechanical Systems, Risk Management, Project Leadership, Cross-functional Collaboration, Analytical Thinking, Effective Communication, Technical Writing, Structured Problem-Solving, ISO 14971, QMS Compliance, FDA Part 820, ISO 13485, CAPA, Data Analysis

Industry

Biotechnology Research

Description

Join our dynamic team at DEKA and be at the forefront of solving complex technical challenges! As our Quality Engineer focused on Failure Investigations, you'll 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 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. 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

Responsibilities

The Quality Engineer will lead and support field return investigations from initiation through closure, ensuring thorough root cause analysis and appropriate corrective actions. They will also analyze field return data and failure modes to identify systemic issues and translate findings into actionable recommendations for improvements.