Quality Engineer I - InHealth Technologies

Reviews/ approves Design Control documentation (e.g. Design Verification, Process, or component validation)
Leads Test Method validation activities associated with Design Verification activities
Represents Quality in New Product Development (NPD) project team meetings & Design Reviews
Prepares and releases Inspection Plans and Quality Control Inspection Criteria (QCICs) that supports qualification of purchased components
Audits Design & Development activities to ensure compliance with procedures and standards
Supports Risk Management activities for new or legacy products. This includes Risk Management Planning (RMP), Risk Analysis including post-market risk assessments, create Risk Management Reports
Leads complaint investigations and trend reporting for InHealth Technologies (IHT) products
Analyze internal and external quality product performance trends and address non-conformities
Represent Quality engineering in Engineering Change Order process for IHT products
Participates in both Internal and/or External audits
Participates in any product recalls or field actions

Bachelor’s degree in Engineering, Sciences or related discipline
Thorough Quality Management training for medical devices (FDA, MDR related)
1 + years demonstrated experience with corrective and preventive actions including formal problem-solving methodologies, critical thinking, and deductive skills
Statistics and statistical analysis software (e.g. Minitab)
Risk Management for Medical Devices (ISO 14971:2019) – knowledgeable in all aspects of risk management processes, including post-market risk assessments related to complaint processing
Ability to create post-market surveillance and useability reports
Well versed in working with Quality Management Systems (21CFR 820 Quality System Regulation and ISO 13485 Quality Management System for Medical Devices)
Experience with GD&T and fixturing is preferred
Experience with Medical Device Directive 93/42/EC and Medical Device Regulation (MDR) 2017/745
Independent and self-direction coupled with a strong desire to work collaboratively as part of a high-performing team
Outstanding written and verbal communication skills
Profound experience in customer interactions regarding complaint resolution
Keen ability to prioritize work and execute
Strong organizational skills; strong technical/ computer skills

Freudenberg Nonwovens, LP