Senior Quality Systems Engineer (Medtech)

TL;DR

Senior Quality Systems Engineer (Medtech): Providing quality systems engineering support for the development and maintenance of medical device products with an accent on CAPA program management and regulatory compliance. Focus on driving root cause analysis, facilitating cross-functional collaboration, and ensuring adherence to ISO 13485 and FDA standards.

Location: Must be based in Lafayette, CO; requires on-site presence four days a week.

Salary: $98,400–$147,600

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life for millions of patients worldwide.

What you will do

• Manage and drive the Corrective and Preventive Action (CAPA) program, including scoping, root cause analysis, and effectiveness verification.
• Provide technical expertise in interpreting regulatory requirements and internal policies to ensure product compliance.
• Support internal and external audits and inspections by leading investigations and resolution efforts.
• Collaborate cross-functionally to maintain quality programs, systems, and procedures.
• Mentor CAPA owners to ensure complete and defendable investigations and action plans.
• Investigate and resolve compliance issues raised by customers, internal units, or regulatory agencies.

Requirements

• Must possess unrestricted U.S. work authorization at the time of hire.
• Bachelor’s degree with 4+ years of experience, Master’s with 2+ years, or PhD with 0 years of relevant experience.
• Proven experience in the medical device industry or a similar regulated field.
• Strong understanding of medical device regulations including EU MDR, FDA, MDSAP, and ISO 13485.
• Experience with ISO 14971 Risk Management and medical device auditing.
• Excellent analytical, communication, and technical writing skills in English.

Culture & Benefits

• Comprehensive health, dental, and vision insurance including HSA and FSA options.
• 401(k) plan with employer contribution and match.
• Paid time off and paid holidays.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan and various incentive plans.
• Global well-being programs and employee assistance services.