ZipRecruiter

Log In

1

Director Root Cause Analysis Jobs in Delaware (NOW HIRING)

Hologic

Product Quality Engineer 2

Newark, DE · On-site

$78K - $122K/yr

Own Investigations and associated root cause analysis, including coordinating collaboration and communication with stakeholders. * Partner with cross functional team and communicate root cause ...

Hologic Inc.

Product Quality Engineer 2

Newark, DE

$78K - $122K/yr

Own Investigations and associated root cause analysis, including coordinating collaboration and communication with stakeholders. * Partner with cross functional team and communicate root cause ...

Socket.dev

Product Quality Engineer 2

Newark, DE · On-site

$78 - $122/hr

Own Investigations and associated root cause analysis, including coordinating collaboration and communication with stakeholders. * Partner with cross functional team and communicate root cause ...

Hologic

Product Quality Engineer 1

Newark, DE · On-site

$54K - $86K/yr

Own Investigations and associated root cause analysis, including coordinating collaboration and communication with stakeholders. * Provide input in prioritization of complaints and investigations ...

Hologic Inc.

Product Quality Engineer 1

Newark, DE

$54K - $86K/yr

Own Investigations and associated root cause analysis, including coordinating collaboration and communication with stakeholders. * Provide input in prioritization of complaints and investigations ...

Keylent Inc

CPQ DEVELOPER

Wilmington, DE · On-site

The role involves working with Salesforce CPQ, conducting root cause analysis for technical issues, and collaborating in an Agile environment to develop and implement solutions. Responsibilities ...

Hologic, Inc.

Product Quality Engineer 3

Newark, DE · On-site

$85.30 - $133/hr

Job Summary Product Quality Engineer will make a direct impact on patient safety and product ... Conduct root cause analyses and coordinate cross‑functional teams to drive timely resolution of ...

Hologic Inc.

Product Quality Engineer 2

Newark, DE

$78K - $122K/yr

In this role, you'll lead complaint investigations, perform root cause analyses, and implement corrective and preventive actions to improve product quality and compliance. Collaborating with cross ...

Hologic

Product Quality Engineer 2

Newark, DE · On-site

$78K - $122K/yr

In this role, you'll lead complaint investigations, perform root cause analyses, and implement corrective and preventive actions to improve product quality and compliance. Collaborating with cross ...

Hologic

Product Quality Engineer 3

Newark, DE · On-site

$85K - $133K/yr

Product Quality Engineer will make a direct impact on patient safety and product excellence by ... Conduct root cause analyses and coordinate cross-functional teams to drive timely resolution of ...

Hologic Inc.

Product Quality Engineer 3

Newark, DE

$85K - $133K/yr

Product Quality Engineer will make a direct impact on patient safety and product excellence by ... Conduct root cause analyses and coordinate cross-functional teams to drive timely resolution of ...

next page

Showing results 1-20

All JobsRoot Cause Analysis JobsDirector Root Cause Analysis JobsDirector Root Cause Analysis Jobs in Delaware

Director Root Cause Analysis information

What is a director root cause analysis?

A Director of Root Cause Analysis is responsible for overseeing the investigation and resolution of systemic issues within an organization. Their primary duties include leading teams to identify the underlying causes of problems, developing corrective action plans, and ensuring that solutions are effectively implemented to prevent recurrence. They also collaborate with other departments to improve processes, maintain compliance with industry standards, and report findings to senior leadership. This role requires strong analytical, leadership, and communication skills.

What are the key skills and qualifications needed to thrive as a director root cause analysis?

To thrive as a Director of Root Cause Analysis, you need expertise in process improvement methodologies, data analysis, and a background in quality management, typically supported by an advanced degree in engineering, business, or a related field. Familiarity with tools like Six Sigma, Lean, statistical analysis software, and root cause analysis frameworks is essential. Exceptional problem-solving abilities, leadership, and strong communication skills help you drive cross-functional teams and foster a culture of continuous improvement. These skills ensure effective identification and resolution of systemic issues, leading to enhanced organizational performance and reduced operational risks.

How does a director root cause analysis typically collaborate with other departments to drive organizational improvements?

A Director of Root Cause Analysis works closely with cross-functional teams, such as operations, quality assurance, engineering, and compliance, to identify and address systemic issues. They often lead or facilitate meetings where stakeholders from different departments contribute insights and data relevant to incidents. By fostering open communication and aligning on shared goals, the director ensures that corrective actions are both practical and sustainable. This collaborative approach not only resolves immediate problems but also drives long-term process improvements across the organization.

What is the difference between Director Root Cause Analysis vs Quality Manager?

AspectDirector Root Cause AnalysisQuality Manager
Primary FocusIdentifying and resolving underlying causes of issuesOverseeing overall quality assurance processes
CertificationsSix Sigma, Lean, Root Cause Analysis certificationsISO 9001, Six Sigma, Quality Management certifications
Work EnvironmentCross-departmental teams, problem-solving sessionsQuality departments, production lines, audits
Industry UsageManufacturing, engineering, healthcareManufacturing, service industries, healthcare

The main difference is that the Director of Root Cause Analysis focuses specifically on diagnosing and solving fundamental problems, while the Quality Manager oversees broader quality assurance and compliance efforts. Both roles require similar certifications and are vital in maintaining high standards within their industries.

What are popular job titles related to Director Root Cause Analysis jobs in Delaware?

For Director Root Cause Analysis jobs in Delaware, the most frequently searched job titles are:

What job categories do people searching Director Root Cause Analysis jobs in Delaware look for?

The top searched job categories for Director Root Cause Analysis jobs in Delaware are:

What cities in Delaware are hiring for Director Root Cause Analysis jobs?

Cities in Delaware with the most Director Root Cause Analysis job openings:

Director Root Cause Analysis jobs near you
Infographic showing various Director Root Cause Analysis job openings in Delaware as of August 2026, with employment types broken down into 80% Full Time, 16% Part Time, and 4% Contract. Highlights an 81% Physical, 5% Hybrid, and 14% Remote job distribution.

Product Quality Engineer 2

Newark, DE • On-site

Hologic
Health Care and Social Assistance • 5 - 10K employees

8.0

Company rating: 8.0 out of 10

Based on 25 frontline employees who took The Breakroom Quiz

181st of 495 rated machine equipment manufacturers

Good employer

Recommended by parents

Respectful managers

Learn more about Hologicexternal

$78K - $122K/yr

Full-time

Re-posted 10 days ago

Job description


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. Lead cross functional team in implementation of improvements or corrections based on the results of complaint investigations.
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.
If you have the right skills and experience, apply today!
#LI-AV1
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

What Hologic employees say

Pay

Benefits

Hours and flexibility

Workplace

Get the full story on Breakroom

Apply