The Quality Engineer Level 4 - Risk Managementis a senior highly experienced individual contributor responsible for leading complex risk management activities across the medical device andor in-vitro diagnostic product lifecycle. The role provides technical leadership for product process software supplier manufacturing service labeling and quality system risk management activities. This position supports new product development sustaining engineering manufacturing post-market surveillance complaints CAPA change management audits and regulatory inspection readiness.
The role works independently applies advanced technical judgment mentors others and partners cross-functionally with Quality Regulatory Affairs R&D Manufacturing Customer Service CommercialSales Supplier Quality and Post-Market teams to ensure risk management practices are technically justified documented inspection-ready and aligned with applicable regulatory requirements.
Knowledge
Strong knowledge of medical device andor IVD risk management principles across the full product lifecycle.
Advanced understanding of applicable regulatory and quality system requirements including FDA Quality System requirementsISO 13485ISO 14971EU IVDRMDSAPOther applicable medical device and IVD standards and regulationsKnowledge 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 FMEAHazard analysisFault tree analysisSafety risk analysisBenefit-risk evaluationUnderstanding 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.
Skills
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.
Behavior
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.
Experience
Significant experience in quality engineering risk management or related roles within the medical device andor 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.
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 120100-188000 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-AV1