Quality Engineer 4 - Risk Management

United States·San Diegomid

EngineeringQuality Engineer

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Requirements Summary

FDA Quality System requirements ISO 13485 ISO 14971 EU IVDR MDSAP Other applicable medical device and IVD standards and regulations Knowledge of design controls, change control, validation, CAPA,

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EngineeringQuality Engineer

Requirements

~1 min read

Strong knowledge of medical device and/or IVD risk management principles across the full product lifecycle.
Advanced understanding of applicable regulatory and quality system requirements, including:
- FDA Quality System requirements
- ISO 13485
- ISO 14971
- EU IVDR
- MDSAP
- Other applicable medical device and IVD standards and regulations
Knowledge of design controls, change control, validation, CAPA, complaint handling, post-market surveillance, nonconformance management, and quality system processes.
Understanding of risk management file structure, content, maintenance, remediation, and inspection readiness expectations.
Knowledge of risk analysis tools and methods, including:
- FMEA
- Hazard analysis
- Fault tree analysis
- Safety risk analysis
- Benefit-risk evaluation
Understanding of how product, process, supplier, software, manufacturing, service, and labeling changes may affect hazards, risk controls, residual risk, and overall risk acceptability.
Familiarity with audit and inspection expectations for risk management documentation and quality engineering deliverables.

Ability to lead complex product, process, and quality system risk assessments.
Strong technical judgment and ability to make risk-based decisions.
Ability to develop, review, maintain, and remediate risk management files and related quality engineering deliverables.
Strong cross-functional facilitation skills, including leading technical risk discussions with clinical, product, engineering, manufacturing, quality, regulatory, and post-market subject matter experts.
Ability to assess post-market data such as complaints, nonconformances, deviations, service records, adverse event trends, customer feedback, and quality signals.
Skilled in identifying gaps, inconsistencies, and improvement opportunities in risk documentation, design files, manufacturing documentation, CAPA records, complaint investigations, and change assessments.
Strong problem-solving skills, including root cause analysis and risk-based prioritization.
Ability to support audits, regulatory inspections, supplier audits, notified body assessments, and inspection readiness activities.
Strong documentation skills to ensure risk conclusions are objective, justified, complete, consistent, and aligned with regulatory requirements.
Ability to mentor less experienced engineers and cross-functional team members on risk management practices and tools.

Operates with a high degree of independence and accountability.
Demonstrates sound technical judgment in complex and ambiguous situations.
Proactively identifies risk management gaps, compliance concerns, and improvement opportunities.
Escalates significant safety, compliance, residual risk, or unresolved risk acceptability concerns to appropriate leadership or governance forums.
Collaborates effectively across functions and sites to integrate risk management into the quality management system.
Drives risk-based decision-making and continuous improvement.
Maintains a strong focus on patient safety, product quality, compliance, and inspection readiness.
Communicates clearly and objectively with technical and non-technical stakeholders.
Provides leadership without direct authority by influencing teams and guiding risk management practices.
Supports a culture of quality, compliance, transparency, and continuous improvement.

Significant experience in quality engineering, risk management, or related roles within the medical device and/or IVD industry.
Experience leading risk management activities across new product development, sustaining engineering, manufacturing, supplier-related changes, post-market surveillance, complaints, CAPA, and change management.
Experience serving as a technical risk management representative on complex cross-functional project teams, design reviews, change review boards, CAPA teams, complaint investigations, and material review activities.
Experience developing, maintaining, reviewing, and improving risk management files and related deliverables.
Experience conducting and facilitating complex FMEAs, hazard analyses, fault tree analyses, safety risk analyses, and product risk assessments.
Experience evaluating product, process, supplier, software, manufacturing, service, or labeling changes for impact to hazards, risk controls, residual risk, and benefit-risk conclusions.
Experience supporting internal audits, external audits, regulatory inspections, supplier audits, and notified body assessments.
Experience mentoring Quality Engineers and cross-functional partners on risk management principles, FMEA practices, hazard analysis, risk control effectiveness, and risk-based decision-making.

What We Offer

~1 min read

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 $120,100 - $188,000 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.

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