Product Quality Engineer 1

Hologic•Newark, DE

12d•$54,900 - $86,000

About The Position

Provide product quality engineering support for on-market medical devices. This role will be responsible for performing evaluations, investigation, risk assessment and root cause analysis in relation to post market feedback and complaints from the field. Works with cross functional team in implementation of improvements or corrections based on the results of complaint investigations.

Requirements

Bachelor’s Degree in Engineering (Mechanical, Electrical or Biomedical preferred)
Bachelor's degree required in either Mechanical, Biomedical, Biomechanical, or Electrical Engineering with 0-2 years experience.
Familiarity with FDA Quality System Regulations, especially Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14970, Risk Management, GMP, and GDP.
Ability to effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution.
Ability to appropriately assess written product and project documentation as an advocate for compliance, and ability to effectively communicate assessment.
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

Nice To Haves

Experience in an FDA regulated industry preferred
Experience in root cause analysis or product development/R&D is beneficial
Familiarity with test method validation, root cause failure analysis, statistical methods, and 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.

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 team and communicate root cause, determine if CAPA is required, recommended changes and scope effort to implement changes as needed.
Partner with internal team to perform the Health Risk Assessment and coordinate with internal teams when needed; must demonstrate efficient and effective analysis of situation, including problem definition and impact.
Participates 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 and owning preparation and presentation of data and findings to internal stakeholders where applicable.
Participate in projects to implement design or process change including drawing update, fixture and tooling update, performing testing and change control documentation, as applicable.
Develop or improve testing methods used during complaint investigation and root cause activities.
Support 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, 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.
Developing professional expertise, applying company policies and procedures to resolve a variety of issues. Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
Support PMQA team investigations in the field at customer sites, working to provide timely resolution of field quality issues while upholding the Hologic brand image and values.
Support data analysis for product quality metrics to Leadership, providing root cause where applicable and recommending actions/resolutions.
Active participation in internal and external audits, including but not limited to facility and supplier audits and Notified Body and FDA inspections.
Supports monthly Quality Investigation Review boards, preparing and presenting material where applicable.