Head of Quality & Regulatory

ProEdge Dental • Centennial, CO

1d • $140,000 - $175,000 • Hybrid

About The Position

ProEdge Dental Compliance Labs is seeking a senior quality leader and Management Representative to own the company’s Quality Management System (QMS), exercise release and stop-ship authority, represent the company before FDA and EPA, and report directly to the President. The role leads a small team and collaborates across the organization to ensure products deliver promised value to customers.

The position is responsible for operating and improving the QMS, including 21 CFR 820 (QMSR) and ISO 13485 processes such as CAPA, complaints, MDR, internal audits, supplier quality, and management review. The Head of Quality & Regulatory assesses inspection readiness, supports regulatory inspections, and helps ensure the organization is prepared for FDA, EPA, and potentially other regulators.

The role also supports new product launch readiness through process validation, risk management, and sound release decisions; oversees quality relationships with co-manufacturers and suppliers; and works hands-on with operations and engineering on prevention and process improvement. The quality leader is expected to build a trusted culture of quality across the organization, contributing both on the production floor and at the Senior Leadership Team table.

This is an in-office role with hybrid flexibility. The core schedule is 8:00 AM to 5:00 PM, Monday through Friday, with the bulk of the time expected to be spent on site.

Requirements

• At least 8 years of experience in medical device quality.
• At least 3 years as an accountable quality lead or Management Representative.
• Experience hosting FDA inspections, responding to investigators, and writing responses that close findings.
• Ownership of CAPA, complaints, MDR, and management review processes.
• Knowledge of 21 CFR 820 (QMSR), ISO 13485, ISO 14971, and 21 CFR 803/807 obligations for an initial importer.
• Willingness to learn EPA, Health Canada, and other international requirements.
• Within the last two years, personal experience writing an investigation, running an audit, or making a release decision.
• A record of measurably reducing defects, recurrence, or variability through a quality program.
• Technical depth to assess validation, SPC charts, and root-cause analyses and recognize when conclusions are unsupported.
• Hands-on, team-first, transparent, calm, persistent about root cause, and discerning in decision-making.
• Willingness to work primarily on site and collaborate directly with the team on the floor.

Nice To Haves

• EPA experience.
• Health Canada experience.

Responsibilities

• Own and operate the Quality Management System end to end, including 21 CFR 820 (QMSR) and ISO 13485 requirements.
• Serve as Management Representative and own CAPA, complaints, MDR, internal audits, supplier quality, and management review.
• Hold release and stop-ship authority.
• Represent ProEdge before FDA, EPA, and potentially other regulators, and assess and maintain inspection readiness.
• Ensure new product launch readiness through process validation, risk management, and appropriate release decisions.
• Oversee quality for co-manufacturers and suppliers, including knowledge of their facilities, data, and quality agreements.
• Work hands-on with operations and engineering on SPC, process capability, root-cause analysis, first-pass yield, and process improvement.
• Lead investigations and corrective actions with the people closest to the work, identify root causes, and ensure fixes remain effective.
• Bring quality and regulatory perspectives to Senior Leadership Team decisions and integrate quality as a strategic partner across the organization.
• Lead a small quality team and collaborate across the organization to deliver value to customers.

Benefits

• Salary range of $140,000 to $175,000 per year.
• 10% annual bonus based on performance and profitability.
• Employee medical, dental, and vision coverage, with spouse and dependent contributions.
• 401(k) matching of 4% pre-tax.
• Four weeks of accrued PTO.
• One week of paid synchronized organizational rest at year-end.
• Six additional paid holidays.
• Hybrid flexibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed