Lead Risk Management Quality Engineer

Hologics mission is to enable healthier lives everywhere every dayand robust risk management is critical to that mission. Were looking for a Lead Risk Management Quality Engineer to ensure the safety and compliance of both onmarket and premarket medical devices by serving as the organizations key risk this highimpact role youll lead risk management activities across the product lifecycle drive improvements to risk processes and procedures and mentor teams in bestinclass risk practices. If you enjoy influencing systems shaping strategy and translating complex risks into clear datadriven decisions this role is for you.

Knowledge

• Deep expertise in ISO 14971:2019 (Risk Management for Medical Devices) and EU MDR (2017/745) risk requirements.
• Strong understanding of FDA Quality System Regulations (21 CFR Part 820 and 860) and ISO 13485.
• Indepth knowledge of industry best practices and emerging trends in risk management processes tools and technologies.
• Working knowledge of verification and validation requirements in the medical device industry.
• Understanding of requirements analysis including development of testable and measurable specifications.
• Preferred: Knowledge of design controls postmarket surveillance and root cause failure analysis.
• Familiarity with complex medical devices (software electromechanical systems) at the system level.

Skills

• Proven ability to own and author risk analyses and other risk management documentation (hazard identification risk evaluation risk controls residual risk assessments).
• Skilled in performing gap assessments planning organizing executing and reporting risk management activities and remediation projects.
• Experience developing and improving risk management processes procedures tools and practices for continuous improvement.
• Ability to develop and implement key performance indicators (KPIs) and metrics to monitor risk management process performance.
• Strong statistical acumen beyond basic SPC including use of statistical techniques to support risk assessments (e.g. probability of hazardous situations).
• Capable of effectively supporting Health Risk Assessments and Health Hazard Evaluations as part of postmarket surveillance.
• Strong communication skills to act as the principal advocate for risk management clearly assessing documentation and conveying risk recommendations to stakeholders.
• Proven ability to lead crossfunctional project teams taking ownership of critical tasks to ensure timely and appropriate completion.
• Demonstrated ability to teach coach and train others in risk management practices from individual mentoring to group training sessions.

Behaviors

• Operates with a high degree of independence demonstrating sound judgment in managing priorities and resolving conflicts.
• Acts as a risk champion consistently advocating for patient safety and robust riskbased decisionmaking.
• Collaborative and influential able to work effectively with R&D Quality Regulatory Operations and PostMarket teams.
• Detailoriented and systematic ensuring risk files are complete compliant and clearly traceable.
• Proactive and improvementfocused continually seeking opportunities to strengthen risk processes and build organizational risk competency.
• Clear concise communicator who can simplify complex risk concepts for a variety of audiences and skill levels.

Experience

• Bachelors Degree in Engineering required (Mechanical Electrical Biomechanical or Biomedical preferred).
• 7 years of experience with a Bachelors degree in Mechanical Biomedical Biomechanical Electrical Engineering or related field.
• Experience in an FDAregulated industry is required with direct ownership of risk analysis and risk management documentation.
• Beneficial: Experience supporting complex medical devices (software or electromechanical) at the system level.

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 $119300-$186600 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 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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