Quality Engineer II – Inhealth Technologies
| Company | Freudenberg Group |
|---|---|
| Location | Carpinteria, CA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Mid Level |
Requirements
- Bachelor’s degree in Engineering, Sciences or related discipline
- Thorough Quality Management training for medical devices (FDA, MDR related)
- 3 + 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 usability reports
- Well versed in working with Quality Management Systems (21CFR 820 Quality System Regulation and ISO 13485 Quality Management System for Medical Devices)
- 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
Responsibilities
- 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
Preferred Qualifications
- Experience with GD&T and fixturing is preferred
- Experience with Medical Device Directive 93/42/EC and Medical Device Regulation (MDR) 2017/745