Sr Quality Engineer (Risk Management)

Location: Lafayette, Colorado, United States of America; onsite at least 4 days per week.

Salary: $98,400.00–$147,600.00 per year; eligible for the hirify.global Incentive Plan.

Company

hirify.global develops medical technologies, services, and solutions across healthcare markets, with a focus on improving patient health and safety.

What you will do

• Develop and maintain risk management strategies, plans, reports, reviews, and the complete risk management file throughout the product lifecycle.
• Lead hazard and risk analyses, DFMEAs, Process FMEAs, and User FMEAs, implementing effective risk controls and evaluating the safety impact of design changes.
• Collaborate with cross-functional surgical operating unit and new product development teams to ensure product quality, patient safety, and traceability between requirements, design outputs, and the risk management file.
• Review product complaints and lead field issue evaluations, including root cause analysis, risk evaluation, and product containment during initial launch.
• Develop post-market surveillance plans and integrate product security measures into risk management activities.
• Support quality system processes, design reviews, validation and verification, statistical processes, regulatory audits, inspections, and technical documentation.

Requirements

• Bachelor’s degree in engineering or a related technical field.
• In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant regulatory standards.
• Strong analytical and problem-solving skills, including thorough root cause analysis.
• Excellent written and verbal communication skills and the ability to collaborate with cross-functional teams and present complex information to stakeholders.
• Proven leadership and project management skills, including leading teams and managing multiple projects simultaneously.
• Unrestricted U.S. work authorization is required at the time of hire and throughout employment; sponsorship is not available for roles below Principal level.
• For bachelor’s degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Nice to have

• Advanced degree.
• Certified Quality Engineer, Six Sigma Green Belt, equivalent certification, or AAMI design control certification.
• Experience in a regulated engineering field and the medical device industry.
• Proficiency in quality management systems, risk management, regulatory compliance, and statistics.
• Basic knowledge of human anatomy, physiology, and surgical procedures.

Culture & Benefits

• Onsite collaboration and in-person exchanges are emphasized, with a minimum of four onsite days per week.
• Health, dental, and vision insurance, plus Health Savings Account and Healthcare Flexible Spending Account options for eligible regular employees.
• Life insurance, long-term and short-term disability coverage, dependent daycare spending account, and employee assistance program.
• Paid time off, paid holidays, tuition assistance or reimbursement, and paid sick time where applicable.
• 401(k) plan with employer contribution and match, employee stock purchase plan, incentive plans, and additional retirement benefits.