Home › Companies › Ebwb Fa Us2 Oraclecloud Com CX › Product Quality Engineer II
Product Quality Engineer II
Ebwb Fa Us2 Oraclecloud Com CX · Newark, DE, United States · Active · $78,000–$122,100 / year · Oracle Recruiting Cloud / Fusion HCM
Job facts
| Field | Value |
|---|---|
| Company | Ebwb Fa Us2 Oraclecloud Com CX |
| Title | Product Quality Engineer II |
| Normalized title | - |
| Department / team | Technical & Engineering |
| Location | Newark, DE, United States |
| Work model | - |
| Employment type | Full Time |
| Salary | $78,000–$122,100 / year |
| Status | active |
| ATS provider | Oracle Recruiting Cloud / Fusion HCM |
| Posted / first seen | 2026-01-08 / 2026-05-31 |
| Changed / last seen | 2026-05-31 / 2026-06-22 |
Related slices
| Page | What it contains | Open |
|---|---|---|
| Company jobs | Active postings from Ebwb Fa Us2 Oraclecloud Com CX. | Open |
| Company breakdowns | Role, location, ATS, and work model facets for this company. | Open |
| ATS provider jobs | Active postings observed through Oracle Recruiting Cloud / Fusion HCM. | Open |
| Provider filtered search | The same provider as a filtered job collection. | Open |
| City jobs | Active postings in Newark. | Open |
| Department jobs | Active postings in Technical & Engineering. | Open |
| Lifecycle events | Open, update, close, and reopen events for this posting. | Open |
| Original posting | Canonical source or apply URL captured from the ATS. | Open |
Linked records
| Company | Ebwb Fa Us2 Oraclecloud Com CX |
| Source | 45e5c258-c76c-4602-ad1e-4a90b4d40832 |
| ATS provider | Oracle Recruiting Cloud / Fusion HCM |
Description
Description
Are you passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a Product Quality Engineer 2 to provide engineering support for on-market medical devices. 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-functional teams, you’ll drive process improvements, assess risks, and deliver impactful solutions that enhance patient safety and customer satisfaction. If you’re a proactive problem-solver with a strong background in quality engineering, we encourage you to apply and make a difference in healthcare innovation.
Knowledge:
Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14971 (Risk Management), GMP, and GDP.
Familiarity with root cause analysis tools, risk management principles, and compliance frameworks.
Preferred knowledge of test method validation, statistical methods, design of experiments (DOE), and industry standards related to reliability, sterilization, packaging, and biocompatibility.
Skills:
Proven ability to lead complaint investigations, root cause analyses, and CAPA activities to resolve quality issues.
Strong data analysis and trending skills to identify risks, assess failure modes, and recommend mitigations.
Effective communication and presentation skills to articulate findings, root causes, and recommendations to stakeholders and leadership.
Ability to assess product changes for design and risk management impact, ensuring compliance and quality standards are maintained.
Proficiency in developing or improving testing methods for complaint investigations and technical activities.
Experience collaborating with cross-functional teams, including Operations, R&D, and Engineering, to drive product and process improvements.
Preferred: Familiarity with verification and validation requirements and the development of testable and measurable specifications.
Behaviors:
Detail-oriented and compliance-focused, ensuring adherence to regulatory standards and quality system requirements.
Proactive and results-driven, with a strong sense of ownership for deliverables and outcomes.
Collaborative and team-oriented, building productive relationships across functions to drive quality improvements.
Customer-focused, with a commitment to addressing field quality issues and ensuring timely resolution.
Continuous improvement mindset, driving process optimization and identifying opportunities to enhance product quality.
Experience:
Bachelor’s degree in Engineering (Mechanical, Biomedical, Biomechanical, Electrical, or related discipline) required.
2–5 years of experience in quality engineering, product development, or R&D, preferably in an FDA-regulated industry.
Hands-on experience in complaint investigations, root cause analysis, and CAPA activities.
Familiarity with internal and external audits, including Notified Body and FDA inspections.
Why join Hologic?
We are committed to making Hologic the destination for top talent. 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.
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, education, business needs and market demand.
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.
#LI-NT1
Full job record
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| Org ID | 5164349e-0c03-47f4-acb1-2ba465d520b2 |
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| Board ID | 45e5c258-c76c-4602-ad1e-4a90b4d40832 |
| Provider | oracle_hcm |
| Provider Job Key | 10334 |
| Title | Product Quality Engineer II |
| Normalized Title | — |
| Status | active |
| Active | yes |
| Location Text | Newark, DE, United States |
| Department | Technical & Engineering |
| Team | — |
| Employment Type | full_time |
| Workplace Type | — |
| Remote Policy | — |
| Country | United States |
| Region | DE |
| City | Newark |
| Salary Raw | salary range for this role is $78,000-$122,100 and is bonus eligible |
| Salary Min | 78,000 |
| Salary Max | 122,100 |
| Salary Currency | USD |
| Salary Period | year |
| Source URL | https://ebwb.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX/job/10334 |
| Apply URL | https://ebwb.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX/job/10334 |
| First Seen At | 2026-05-31 17:59:24Z |
| Last Seen At | 2026-06-22 14:53:47Z |
| Last Checked At | 2026-06-22 14:53:47Z |
| Last Changed At | 2026-05-31 17:59:24Z |
| Inactive At | — |
| Source Posted At | 2026-01-08 18:23:17Z |
| Source Updated At | — |
| Raw Payload Uri | s3://job-postings-prod-raw-590183727216/raw/provider=oracle_hcm/board=ebwb.fa.us2.oraclecloud.com|CX/date=2026-06-22/2026-06-22T14-53-28-208Z-1ef4a737eb2c404d44fd0cc7819714b86dc141cfc0ba4eb8b0ae5f0130cf1d1f.json |
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