Director of Quality

Elutia; Gaithersburg (MD); On-site; USD 160,000 - 200,000; Full time

Benefits offered by this job

Equity

Performance-based bonus

Medical

Dental

Vision

Life insurance

401(k) match

Paid time off

Job summary

Elutia in Gaithersburg, MD is seeking a Director of Quality to lead the strategy for a robust QMS across R&D, Regulatory, and Operations. You will drive design controls, compliance with 21 CFR Part 820, ISO 13485, and risk management, while partnering to embed a culture of quality and continuous improvement.

This is a high-visibility role with accountability for product safety and regulatory readiness. Expected salary range is $160k-$200k with equity eligibility and a comprehensive benefits

Qualifications

• Minimum 10+ years in a quality leadership role.
• BS in a scientific discipline required.
• Extensive FDA/ISO regulated environment experience with QSR and ISO 13485.
• Healthcare industry experience in manufacturing or R&D settings.

Responsibilities

• Design, implement and maintain the QMS across operations.
• Lead regulatory interactions with FDA and Notified Bodies.
• Oversee CAPAs, investigations, and post-market surveillance.
• Drive design controls and V&V activities for new products.
• Mentor and develop the Quality organization.

Skills

Quality Management

Regulatory Affairs

Leadership

Risk Management

QMS Compliance

Education

BS in a scientific discipline

Tools

Document Control

CAPA Management

Quality Metrics

Job description

Each year, more than 150,000 breast reconstruction procedures are performed in the U.S., yet one in three patients still faces a serious complication. That is not good enough. At Elutia, we are working to change it.

Our mission is to humanize medicine so patients can thrive without compromise. We are pioneering drug-eluting technologies to improve the interface between medical devices and the patients who rely on them.

How we work matters just as much as what we make. Elutia is a certified Great Place to Work®, grounded in our CRU values: Contagiously Confident, Ridiculously Relentless, and Unanimously United. We set a high bar for ourselves, for each other, and for the outcomes we deliver.

Our team is All In on the mission. This is not the place for someone looking to coast. It is the place for someone who wants to solve hard problems, move with urgency, and make a real mark on medicine, alongside a team fully committed to improving patient outcomes.

The Opportunity

The Director of Quality is a strategic leader responsible for defining and executing Elutia’s quality vision and ensuring a robust, compliant Quality Management System (QMS) across all operations. The Director, Quality, partners closely with R&D, Regulatory Affairs, and Operations to embed a culture of quality and continuous improvement throughout the organization. This leader ensures that all products meet regulatory, internal, and customer standards while enabling innovation and operational excellence.

Key Responsibilities

Quality Systems & Compliance

• Design, establish, implement and maintain Elutia’s quality systems to comply with regulatory requirements, including Quality System (QSR) Regulation (21 CFR part 820) for Medical Devices, required provisions from drug current Good Manufacturing Practice (21 CFR Part 211) in accordance with 21 CFR 4.4(b)(2) (device QS regulation-based streamlined approach) for combination drug-device products, 21 CFR Part 1271 for Human Cells, Tissues, and Cellular and Tissue Products, and ISO 13485, as applicable to Elutia Inc. business requirements.
• Manage and oversee a robust Quality Management System, including Document Control, Quality Assurance, Supplier Management, Production and Process Controls, Investigations and CAPAs, Complaints, Post-Market Surveillance programs, Quality Planning, and Quality Metrics.

Design Control & Product Development

• Provide leadership in Design Control, leading development of the Design History File (DHF), Device Master Record (DMR), Failure Modes and Effects Analysis (FMEA), and Verification and Validation (V&V).
• Provide leadership in product Design Verification testing, biocompatibility assessments, product/process qualifications, and validation activities to establish the safety and efficacy of developed products, including risk management profiles for Elutia products.
• Lead or participate in multidisciplinary teams for new product development and/or to resolve complex product investigations.

Qualification, Validation & Site Launch

• Provide leadership in the qualification of new products and processes, including facility and equipment qualification, process qualification, packaging development and qualification, sterilization validation, and product stability programs.
• Author, review, and approve procedures, specifications, policies, and quality plans to support the launch of a new manufacturing site and two new manufacturing processes.

Quality Leadership & Regulatory Interface

• Hire, manage, train, and develop the talents and capabilities of the Quality organization.
• Update Executive Management on the performance of the quality system and any need for improvement using established metrics and reports.
• Manage, interact, and communicate with FDA, notified bodies, and regulators during on-site audits/inspections, field actions, recalls, or post-market surveillance/vigilance activities.

Qualifications

Required

• 10+ years of experience in a Quality Management role
• BS in a scientific discipline required.
• Extensive quality experience in an FDA and ISO regulated environment, with specific knowledge of Quality System (QSR) Regulation (21 CFR Part 820) for Medical Devices, required provisions from drug current Good Manufacturing Practice (21 CFR Part 211) in accordance with 21 CFR 4.4(b)(2) (device QS regulation-based streamlined approach) for combination drug-device products, and ISO 13485. Knowledge of 21 CFR Part 1271 for Human Cells, Tissues, and Cellular and Tissue Products is ideal but not required.
• Significant experience in the healthcare industry (medical device and/or combination products), both in Operational / Manufacturing and R&D/Product development environments.

Preferred

• ASQ Certified Quality Engineer (CQE) or ASQ Certified Quality Auditor (CQA) preferred.
• Demonstrated capability in business process/system management and improvement.
• Experience interfacing with government and accreditation agencies (FDA, ISO, Notified Bodies), managing audits and supporting regulatory filings, responses, and other documents required in a regulated environment.
• Strong leadership skills; demonstrated ability to clearly develop and articulate short-term goals and objectives to drive performance and results.
• Experience writing and reviewing Quality System documents. The person in this role will be expected to take a hands‑on role in bringing up the facility and manufacturing processes.
• Experience working in a lean team environment, balancing multiple priorities.
• Experience working with tight timelines, ensuring that project deadlines are met without impacting quality.

What Success Looks Like

The successful candidate will:

• Be someone technical teams engage early when developing, scaling, validating, or changing a manufacturing process.
• Help translate development work into robust, controlled, and scalable manufacturing processes.
• Independently move Quality and process‑related activities from problem identification through resolution.
• Use strong engineering judgment and risk‑based decision‑making to determine an appropriate level of testing, controls, and documentation.
• Keep important Quality System activities moving while simultaneously supporting scale‑up and manufacturing priorities.
• Be comfortable shifting between technical process work and hands‑on Quality System execution as business needs require.
• Produce practical, technically defensible solutions that protect product quality and patient safety while meeting regulatory requirements.

Who Thrives Here

This place isn’t for everyone. At Elutia, we are All In on the mission. This place is built for people who want to compete at a high level, solve hard problems, and do work that matters deeply to patients. The people who thrive here are confident without being arrogant, relentless without being rigid, and team‑first to the core. They do not seek comfort, politics, or a carefully managed environment. They want the challenge. They want the ownership. They want to be on a team with other exceptional people and win.

This isn’t just a job. It is a mission. Priorities shift. Problems hit fast. Constraints are real. We are looking for those who thrive here, rise to the moment, course‑correct unapologetically, and stay locked on the goal line. If someone is looking for comfort, clean boundaries, or a lower‑stakes ride, this is the wrong place. If they want to build something meaningful with a team of superstars and leave everything on the field, they will belong here.

• All in on the mission
• Confident, not arrogant
• Calm under pressure and decisive in critical moments
• Obsessed with outcomes, not status
• Fast to adapt and hard to rattle
• Energized by hard problems and high standards
• More interested in winning championships than MVPs

Expected salary range: $160,000-200,000, depending on experience and qualifications.

This role is eligible for equity and a performance‑based bonus. Elutia also offers a comprehensive benefits package, including medical, dental, vision, life, 401(k) with employer match, and paid time off.

Elutia is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.