TheQuality Engineer Level 3 - Risk Managementis an experienced individual contributor within Regulatory and Quality for Diagnostics. This role is responsible for performing and maintaining product and process risk management activities for medical device andor in-vitro diagnostic products across the full product lifecycle. The position supports new product development sustaining activities manufacturing supplier quality post-market surveillance complaints CAPA nonconformances and change management.
The role partners with cross-functional teams including Quality Regulatory Affairs R&D Manufacturing Customer Service CommercialSales Supplier Quality and Post-Market teams to ensure risk management activities are completed in accordance with applicable quality system requirements FDA regulations ISO 13485 ISO 14971 and other relevant medical device and IVD regulatory expectations.
Knowledge
Product and process risk management principles for medical devices and IVD products.
FDA Quality System requirements and applicable regulatory expectations.
ISO 13485 and ISO 14971 requirements.
QSR CDRH IVDR MDR MDSAP and IEC 62304 regulations and standards.
Design controls and their relationship to risk management.
Hazard analysis use-related risk assessment fault tree analysis DFMEA PFMEA safety risk analysis product risk assessments and benefit-risk evaluations.
Complaint handling CAPA nonconformance change control validation and post-market surveillance processes.
Root cause analysis and corrective action methods.
Technical documentation including requirements specifications verification and validation reports manufacturing procedures quality records and risk files.
Audit and inspection readiness expectations for internal audits external audits regulatory inspections and supplier audits.
Skills
The successful candidate should demonstrate the ability to
Independently perform assigned risk management activities across product development manufacturing sustaining and post-market lifecycle phases.
Develop review maintain and evaluate risk management documentation and deliverables.
Assess whether product process software supplier manufacturing service or labeling changes introduce new hazards or affect existing risk controls.
Identify verify and evaluate the effectiveness of risk controls.
Interpret technical documentation and identify quality compliance or risk implications.
Produce clear objective technically accurate and inspection-ready documentation.
Apply analytical thinking problem-solving root cause analysis and risk-based decision-making.
Support cross-functional teams design reviews change review boards CAPA teams complaint investigations and material review activities.
Provide subject matter input during audits inspections and readiness activities.
Manage multiple priorities and meet project timelines in a dynamic regulated environment.
Communicate effectively through written verbal and interpersonal interactions.
Behavior
Works independently on defined assignments while recognizing when escalation is needed.
Demonstrates strong attention to detail and a commitment to high-quality standards.
Collaborates effectively with stakeholders across Quality Regulatory R&D Manufacturing Supplier Quality Customer Service CommercialSales and Post-Market teams.
Maintains objectivity and technical accuracy in risk documentation and assessments.
Supports a culture of compliance inspection readiness and continuous improvement.
Escalates complex risk questions safety concerns or unresolved risk acceptability issues to management or senior technical leaders.
Contributes constructively to cross-functional decision-making and risk-based discussions.
Adapts to changing priorities while maintaining focus on quality compliance and product safety.
Experience
A minimum of a Bachelors degree in engineering life sciences biomedical sciences quality or a related technical discipline.
5 years of related experiencein a regulated medical device IVD quality engineering or product development environment.
Experience supporting risk management files hazard analyses FMEAs design control documentation change control complaints CAPA andor nonconformance processes.
Experience working on cross-functional teams in regulated product development or sustaining engineering environments.
Experience evaluating post-market information such as complaints deviations nonconformances service data and other feedback for potential risk impact.
Experience supporting internal audits external audits regulatory inspections supplier audits and inspection readiness activities.
Practical experience reviewing and maintaining risk files throughout product development manufacturing and post-market surveillance phases.
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 98500-154000 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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