Principal Quality Systems Engineer (Medtech)

TL;DR

Principal Quality Systems Engineer (Medtech): Overseeing the development and maintenance of quality programs and regulatory systems with an accent on compliance, audit resolution, and process standardization. Focus on interpreting complex governmental regulations and implementing systemic improvements to ensure global service quality.

Location: Onsite in Lafayette, Colorado, USA

Salary: $114,400 – $171,600

Company

hirify.global is a global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life through ambitious engineering and innovation.

What you will do

• Oversee the development and maintenance of quality programs and processes to ensure compliance with internal and external standards.
• Provide expert guidance on the interpretation of regulatory and governmental regulations to assure organizational compliance.
• Lead audit and inspection preparation, resolve findings, and liaise with auditing groups throughout all stages.
• Prepare reports and Corrective and Preventative Actions (CAPA) for internal and external stakeholders.
• Coordinate legal requests in support of government investigations or litigations.
• Facilitate uniform standards worldwide and enable best practice sharing to support the company's global mission.

Requirements

• Must be authorized to work in the USA (H-1B, TN, J sponsorship is available for this Principal-level role).
• Baccalaureate degree with a minimum of 7 years of relevant experience, or an advanced degree with at least 5 years of experience.
• Mastery of a specialty area and full knowledge of industry quality practices.
• Proven ability to manage large projects or processes independently with limited oversight.
• Strong communication and negotiation skills for dealing with internal/external customers and vendors.

Culture & Benefits

• Comprehensive health, dental, and vision insurance with Health Savings Account (HSA) and Flexible Spending Account (FSA) options.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and short/long-term disability leave.
• Employee Stock Purchase Plan and tuition assistance/reimbursement.
• Global well-being program (Simple Steps) and Employee Assistance Program.
• Short-term incentive eligibility via the hirify.global Incentive Plan (MIP).