Product Quality Engineer 1
$54,900–$86,000 year
On-siteNewark, Delaware, United States
Job Summary
Conduct post-market investigations, root cause analysis, and risk assessments for medical devices based on field complaints and feedback. Partner with cross-functional teams to implement corrections, determine CAPA requirements, and present data findings to stakeholders. Perform data analysis and trending to identify mitigations for threshold risks, while supporting design or process change projects including testing and documentation. Provide technical expertise to the complaint intake team and participate in internal audits, Quality Investigation Review boards, and FDA inspections. Support PMQA team investigations at customer sites to resolve field quality issues.
Required Qualifications
- Bachelor's Degree in Engineering (Mechanical, Electrical or Biomedical)
- Bachelor's degree in either Mechanical, Biomedical, Biomechanical, or Electrical Engineering
- 0-2 years experience
- Experience in an FDA regulated industry
- Experience in root cause analysis or product development/R&D
- Familiarity with FDA Quality System Regulations, especially Design Control requirements
- Familiarity with ISO 13485
- Familiarity with EU Medical Device Regulation
- Familiarity with ISO 14970
- Familiarity with Risk Management
- Familiarity with GMP
- Familiarity with GDP
- Ability to effectively work on project teams
- Ability to appropriately assess written product and project documentation as an advocate for compliance
- Ability to effectively communicate assessment
- Knowledge of root cause analysis tools
- Good communication and presentation skills
Desired Qualifications
- Bachelor's degree in Engineering (Mechanical, Electrical or Biomedical preferred)
- Experience in root cause analysis or product development/R&D is beneficial
- Familiarity with test method validation
- Familiarity with root cause failure analysis
- Familiarity with statistical methods
- Familiarity with design of experiment
- Familiarity with Reliability standards
- Familiarity with Electrical Safety standards
- Familiarity with Sterilization standards
- Familiarity with Packaging standards
- Familiarity with Biocompatibility standards and requirements
- Working knowledge of verification and validation requirements for a regulated product
- Familiarity with requirements analysis
- Knowledge of risk based and statistical analysis concepts
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