Product Quality Engineer 2

Hologic; Newark (DE); On-site; USD 78,000 - 122,000; Full time

Job summary

Hologic, Inc. is seeking a Quality Engineer to lead investigations into product complaints, perform root cause analysis, and drive CAPA implementation. You will partner with cross-functional teams to assess risk, develop improvement plans, and coordinate change controls.

This role requires FDA quality systems knowledge and strong communication skills. The position emphasizes field and internal investigations, data analysis, and presenting findings to leadership.

Qualifications

• Knowledge of FDA Quality System Regulations and ISO 13485.
• Strong root cause analysis and problem-solving skills.
• Excellent communication and presentation abilities.
• Experience leading cross-functional teams.

Responsibilities

• Provide input in prioritization of complaints based on risk, data, and strategic impact.
• Own investigations and root cause analysis, coordinating with stakeholders.
• Collaborate with cross-functional teams, determine CAPA requirements and scope changes.
• Execute Health Risk Assessments and coordinate with internal teams.

Job description

Essential Duties and Responsibilities

• Provide input in prioritization of complaints and investigations based on product risk, data analysis and trending, and strategic impact.
• Own Investigations and associated root cause analysis, including coordinating collaboration and communication with stakeholders.
• Partner with cross functional team and communicate root cause, determine if CAPA is required, recommended changes and scope effort to implement changes as needed.
• Responsible for executing the Health Risk Assessment, and coordinating with internal teams when needed, for evaluation of on market product, must demonstrate efficient and effective analysis of situation, including problem definition and impact.
• Leads cross functional team in implementation 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.
• Lead project 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
• Train and support complaint intake team as needed to provide technical expertise and complex 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.
• Performs investigations in the field at customer sites partnering with field-based teams, including sales and service.Urgently identify and provide timely resolution of field quality issues while upholding the Hologic brand image and values.
• Present product quality metrics to Leadership, explain root cause, and recommend 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.

Qualifications

Education

• Bachelor’s Degree in Engineering (Mechanical, Electrical or Biomedical preferred)

Experience

• Bachelor's degree required in either Mechanical, Biomedical, Biomechanical, or Electrical Engineering with 2-5 years experience

• Experience in an FDA regulated industry preferred

  Experience in root cause analysis or product development/R&D is beneficial

Skills

• Working knowledge of 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 lead root cause activities for complaint investigations, NCs, CAPAs, etc.
• Good communication and presentation skills

• Works with intermediate level of autonomy and independence, requiring minor oversight on complex problems with analysis requiring a variety of factors.

  Preferred:

• 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

The annualized base salary range for this role is $78,000- 122,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.

Why Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.