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Description
Key Responsibilities:
Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
Perform hands-on device investigation using visual, dimensional, and test equipment to determine root cause.
Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed.
Participate in escalation tasks and activities, including Project Risk Assessments (PRA) and Corrective/Preventive action(s) – CAPAs, SCARs, as determination by investigation.
Identify and report key complaint metrics per device category and collaborate with applicable manufacturing engineering teams to resolve production/device related issues.
Other incidental duties assigned by Leadership (May assist in Adhoc complaint analysis or metric review).
Education And Experience
Bachelor’s degree in engineering, 0 – 2 years’ experience related work experience required.
Experience in medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred.
Experience in complaint investigations, root cause analysis, and the associated risk assessments preferred.
Additional Skills
Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills.
Basic understanding of statistical techniques
Previous Experience Working With Lab/industrial Equipment Required.
Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
Solid problem-solving, organizational, analytical and critical thinking skills
Solid understanding of processes and equipment used in assigned work.
Knowledge of and adherence to Quality systems
Strict attention to detail
Ability to interact professionally with all organizational levels.
Ability to manage competing priorities in a fast-paced environment.
Must be able to work in a team environment, including the ability to manage project stakeholders.
Ability to build productive internal/external working relationships.
Education: Bachelors Degree
