Product Quality Engineer 1

Key Responsibilities

• Own investigations and associated root cause analysis, including coordinating collaboration and communication with stakeholders.
• Provide input in prioritization of complaints and investigations based on product risk, data analysis and trending, and strategic impact.
• Partner with cross-functional teams to communicate root cause, determine if CAPA is required, and recommend changes and scope efforts to implement changes as needed.
• Partner with internal teams to perform Health Risk Assessments and coordinate with internal teams when needed.
• Participate in cross-functional team implementation activities of improvements or corrections based on the results of complaint investigations.
• Perform data analysis and trending of data related to complaints and identified failure modes, identifying mitigations for any threshold risks.
• Own preparation and presentation of data and findings to internal stakeholders where applicable.
• Participate in projects to implement design or process change, including drawing updates, fixture and tooling updates, performing testing, and change control documentation, as applicable.
• Develop or improve testing methods used during complaint investigation and root cause activities.
• Support the complaint intake team as needed to provide technical expertise and work through investigation activities.
• Assess changes of products for impact to design and risk management, and determine supporting information required for implementation of changes.
• Provide post-market feedback, identified through complaint trending and other forums, to Operations, Engineering, and R&D to improve design and manufacture of devices in the field and in development.
• Apply company policies and procedures to resolve a variety of issues.
• Support PMQA team investigations in the field at customer sites, working to provide timely resolution of field quality issues.
• Support data analysis for product quality metrics to leadership, providing root cause where applicable and recommending actions/resolutions.
• Participate in internal and external audits, including facility and supplier audits, and Notified Body and FDA inspections.
• Support monthly Quality Investigation Review boards, preparing and presenting material where applicable.

Requirements & Tech Stack

• Familiarity with FDA Quality System Regulations, especially Design Control requirements.
• Familiarity with ISO 13485, EU Medical Device Regulation, ISO 14970, Risk Management, GMP, and GDP.
• Knowledge of root cause analysis tools and ability to effectively participate in root cause activities for complaint investigations, NCs, CAPAs, etc.
• Good communication and presentation skills.

Preferred

• Familiarity with test method validation.
• Familiarity with root cause failure analysis.
• Familiarity with statistical methods.
• Familiarity with design of experiment.
• Familiarity with Reliability, Electrical Safety, Sterilization, Packaging, and Biocompatibility standards and requirements.
• Working knowledge of verification and validation requirements for a regulated product.
• Familiarity with requirements analysis, including development of testable and measurable specifications.
• Knowledge of risk-based and statistical analysis concepts.

Qualifications

• Bachelor’s Degree in Engineering (Mechanical, Electrical or Biomedical preferred).
• Bachelor's degree required in either Mechanical, Biomedical, Biomechanical, or Electrical Engineering.
• Experience in a FDA regulated industry is preferred.
• Experience in root cause analysis or product development/R&D is beneficial.
• Ability to effectively work on project teams, including taking leadership roles on critical tasks to assure appropriate and timely completion/resolution.
• Ability to appropriately assess written product and project documentation as an advocate for compliance.
• Ability to effectively communicate assessments.