Head of Quality & Regulatory

ProEdge Dental; Centennial (CO); Hybrid; USD 140,000 - 175,000; Full time

Benefits offered by this job

Salary $140k–$175k per year

Job summary

ProEdge Dental Compliance Labs is seeking a Head of Quality & Regulatory to own the Quality Management System and serve as Management Representative. You will lead a small team, face FDA and EPA on our behalf, and report to the President.

You will drive product launch readiness, supplier quality, and prevention-focused improvements across the organization, embedding quality as a strategic partner and ensuring compliance with 21 CFR 820 and ISO 13485.

Qualifications

• 8+ years in medical device quality including 3+ as accountable quality lead or Management Representative.
• You've hosted an FDA inspection and answered tough questions with preparedness and honesty.
• You know 21 CFR 820 (QMSR), ISO 13485, ISO 14971, and the obligations of initial importer (21 CFR 803/807).
• You have written investigations, conducted audits, or made release decisions in the last two years.
• You have led quality programs that measurably reduced defects, recurrence, or variability and can explain the prevention approach.

Responsibilities

• Own the QMS end-to-end, including CAPA, complaints, MDR, and management review.
• Be the face to regulators (FDA, EPA) and readiness for inspections.
• Lead new product launch readiness with risk management and process validation.
• Maintain supplier and co-manufacturer quality expectations and risk management.
• Drive prevention through SPC, root-cause analysis, and cross-functional collaboration.
• Embed a culture of quality as a strategic partner across the organization.

Skills

Quality leadership

FDA inspection experience

Regulatory knowledge

CAPA/Complaints/MDR

Management Representative

Education

8+ years in medical device quality

Job description

Head of Quality & Regulatory

Application Deadline: 30 November 2026

Department: Quality

Employment Type: Full Time

Location: Hybrid

Reporting To: President

Compensation: $140,000 - $175,000 / year

Description

About ProEdge Dental Compliance Labs

ProEdge Dental Compliance Labs is a team of selfless builders. By putting our focus on the success of customers, we've created a healthy, quickly-growing, and dynamic company. Our ~60 team members have taken on a significant challenge: transform compliance in the dental practice, often a distinct pain for our customers, into a culture of shared purpose for the safety of patients and staff. By keeping our promises and developing value-based solutions, we've created an emerging brand in dental.

Because of that, at ProEdge, "good work" is table stakes. What we're building requires something rarer from its leaders: those who choose the harder path for the sake of the team, who continue to grow even when they're already good, and who bring the kind of relentless pursuit of delivering concrete value to the customer, not just building a stronger resume. This is a place for low-ego, high-agency problem-solvers who think deeply and execute to excellence.

If you're looking for a role where you can carry quality for a company that wants to get it right and show its importance to customer trust... keep reading.

The Head of Quality & Regulatory opportunity

ProEdge is seeking a Head of Quality & Regulatory to be our senior quality leader and Management Representative. You'll own the Quality Management System, hold release and stop-ship authority, stand in front of FDA and EPA on our behalf, and report directly to the President. You'll lead a small team that collaborates across the organization to ensure promised value is delivered to the customer.

At ProEdge, compliance is the floor and quality is the ceiling. When a regulator walks in, you and the team are prepared. Your job is to move us from catching problems at the end to preventing them at the source, the ProEdge way: on the floor with the people who make the product, at the Senior Leadership Team table where quality shapes what we build next, and in front of a customer when the honest answer is the hard one. When something breaks, you take responsibility for finding the cause and developing the fix with the people closest to the work. Then you make sure it stays fixed.

If you've been promoted away from the work and miss it, or you've never had the title and are ready to prove you can carry it... keep reading.

What Success Looks Like

• The QMS, owned end to end. You run 21 CFR 820 (QMSR) and ISO 13485 as Management Representative: CAPA, complaints, MDR, internal audit, supplier quality. Within your first year, CAPAs stop recurring, complaint trends shape product decisions, and management review drives at least one roadmap or risk decision every quarter, because it's a working session, not a report-out.
• Our face to the regulators. FDA, EPA, and potentially others for our registered products. You've assessed our inspection readiness and told us the truth about it in your first 90 days. 9 months from then, we're ready on any given Tuesday and inspection week, and they leave without a major finding, because the system runs that way every day.
• New product launch readiness. Process validation, risk management, and the judgment to say "not yet" when the data says so. New products launch on schedule and stay launched: no field corrections, no recalls, no surprises, because the risks were found before they ever reached a customer.
• Co-manufacturer and supplier quality. Three of our medical devices are made by partners and sold under our name, so to our customers it's all ProEdge. You help keep those relationships strong and honest: you know their plants, data, and quality agreements are the terms both run by. By 18 months, we're never surprised by a partner issue and partners say working with ProEdge made them better.
• Prevention, hands on. SPC, capability, root cause, first-pass yield, done by you, with our operations engineering team alongside. By 18 months, you've led one or two process improvements with measured gains in yield or variability.
• The culture of quality. Earned on the floor and carried into the Senior Leadership Team, where you'll bring the quality and regulatory view to company decisions and help the rest of us see around corners. By 18 months, Quality is fully integrated, trusted, and supported as a strategic partner across the organization.

Who We Need

The toolkit you'll bring

We're specific here on purpose. If you have most of this and the rest of the posting sounds like you,

• You've stood in the room. You've hosted an FDA inspection, sat across from the investigator, answered the hard question without guessing, and written the response that closed it. You know the difference between being prepared and being defensive from experience.
• You've carried the system. 8+ years in medical device quality, including 3+ as the accountable quality lead or Management Representative. You've owned CAPA, complaints, MDR, and management review, not just reviewed them.
• You know the rules cold. 21 CFR 820 (QMSR), ISO 13485, ISO 14971, and the 21 CFR 803/807 obligations of an initial importer. EPA or Health Canada experience is a real plus; the willingness to learn them and other international requirements is required.
• You still like the work. In the last two years you've personally written an investigation, run a audit, or made a release call, not just approved one.
• You've prevented problems. A quality program you led measurably reduced defects, recurrence, or variability and can tell us how.
• You can challenge the engineering. Enough technical depth to read a validation, an SPC chart, or a root-cause analysis and know when the conclusion doesn't hold. You don't have to run the study yourself. You do have to know when it's wrong.

Who you'll be

• Humble. Team-first and self-improving.
• Hands-on. You enjoy leading the CAPA rather than assigning it. You lead from inside the work, not strictly above it.
• Transparent. You tell the truth even when it puts you in a vulnerable position, to a regulator, to the President, and to your own team.
• Calm in the room. Precise, direct, and never defensive when the questions get hard, especially with regulators.
• Relentless about root cause. You fix systems, not symptoms. You're unsatisfied with checking boxes when prevention was possible.
• Discerning. You make consistently wise decisions, including the unpopular ones, and you can explain the reasoning.

Additional Details

A note about in-office/hybrid

This is an in-office role with a core schedule of 8:00 AM to 5:00 PM, Monday through Friday, with hybrid flexibility. ProEdge genuinely cares about the health of all team members. All of us are real people with real lives: appointments, kids get sick, moments at home we wouldn't dare miss, or the every-so-often need for a deep focus day away from the pop-ins. We're a team that supports each other, including when those realities pop up, and we offer overflowing flexibility.

That said, being the quality leader at ProEdge means you're connected, respected, and trusted by the team on the floor. That happens best when you're here, shoulder to shoulder with your team, the bulk of the time. Remote leadership doesn't deliver the same magic for us. We're looking for someone who genuinely enjoys being part of a great team and wants to help shape our culture of quality in the every day.

Salary & benefits

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