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Director Of Quality And Risk Jobs (NOW HIRING)

Pine Pharmaceuticals

Director of Quality

Tonawanda, NY · On-site

$140K - $170K/yr

This includes oversight of quality assurance, quality control, compliance programs, risk management ... The Director of Quality leads, mentors, and develops the quality organization by building high ...

Factory6, Inc.

Director Of Quality

Lindon, UT · On-site

THE ROLE The Director of Quality leads Factory6's Quality and Food Safety organization within a ... risk management. * Provide quality leadership for product hold, release, rework, rejection ...

NEOGEN CARE

Director of Quality

Ontario, CA · On-site

The Director of Quality partners with clinicians and leadership to identify documentation issues, reduce audit risk, improve quality outcomes, and promote timely, accurate chart completion. Essential ...

NEOGEN CARE

Director of Quality

Sherman Oaks, CA · On-site

The Director of Quality partners with clinicians and leadership to identify documentation issues, reduce audit risk, improve quality outcomes, and promote timely, accurate chart completion. Essential ...

Team JAS, Inc

Director of Quality

Jacksonville, FL · On-site

The Director of Quality will foster a culture of accountability, safety, risk mitigation, and continuous improvement throughout the organization. Primary Responsibilities * Oversee all aspects of the ...

Team JAS, Inc

Director of Quality

Jacksonville, FL · On-site

The Director of Quality will foster a culture of accountability, safety, risk mitigation, and continuous improvement throughout the organization. Primary Responsibilities * Oversee all aspects of the ...

Solve IMG

Director of Quality

Charlotte, NC · On-site

Reporting to the VP of Integration, the Director of Quality is responsible for developing and ... Leverage ERP, QMS, WMS, and data analytics tools to identify trends, mitigate risk, and improve ...

Solve IMG

Director of Quality

Charlotte, NC · On-site

Reporting to the VP of Integration, the Director of Quality is responsible for developing and ... Leverage ERP, QMS, WMS, and data analytics tools to identify trends, mitigate risk, and improve ...

Visby Medical

Director of Quality

San Jose, CA · Remote

About the Job The Director of Quality plays a pivotal role in ensuring that Visby's products meet ... Ensure that risk management activities are effectively used to drive improvement to product quality ...

BMSC

Director of Quality

Fort Worth, TX · On-site

Position Summary The Director of Quality will be responsible for the development, implementation ... risk assessments and provide the most efficient utilization of resources to accomplish departmental ...

Pivotal Systems

Director of Quality

Fremont, CA · On-site

As the Director of Quality, you will play a critical role in ensuring the delivery of high-quality ... Risk Management: Identify and mitigate Quality risks associated with product (Hardware and Software ...

Cox and Company

Director of Quality

Plainview, NY · On-site

Description Director of Quality Cox & Company, Inc. is seeking an outgoing and experienced Director of Quality to lead the development and implementation of our quality management system. This key ...

Colson Group

Director of Quality

Saint Joseph, MI · On-site

Job Title US Director of Quality Company Colson Group USA Reports to VP Of Operations Reporting Roles Dotted reporting lines - Quality Managers and Quality Teams of Colson USA Operations Objectives ...

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$31K

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$213.5K

How much do director of quality and risk jobs pay per year?

As of Jun 7, 2026, the average yearly pay for director of quality and risk in the United States is $125,600.00, according to ZipRecruiter salary data. Most workers in this role earn between $91,000.00 and $151,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Director Of Quality And Risk, and why are they important?

To thrive as a Director Of Quality And Risk, you need deep expertise in quality assurance, risk management, regulatory compliance, and typically an advanced degree in healthcare, business, or a related field. Familiarity with quality management systems (QMS), risk assessment tools, and certifications such as CPHQ (Certified Professional in Healthcare Quality) or Six Sigma is highly valued. Strong leadership, analytical thinking, and effective communication skills set top professionals apart in this role. These skills ensure robust quality standards, minimize organizational risks, and promote a culture of safety and continuous improvement.

What does a Director of Quality and Risk do?

A Director of Quality and Risk oversees the development and implementation of policies and procedures to ensure organizational compliance with quality standards and risk management protocols. They are responsible for identifying potential risks that could impact operations, developing strategies to mitigate those risks, and ensuring that quality assurance initiatives meet regulatory and industry standards. This role often involves leading teams, conducting audits, and collaborating with other departments to promote a culture of safety, quality, and continuous improvement within the organization.

What are some common challenges faced by a Director of Quality and Risk, and how can they be addressed?

A Director of Quality and Risk often encounters challenges such as aligning diverse teams with standardized quality protocols, staying ahead of regulatory changes, and fostering a culture of continuous improvement. Addressing these challenges requires strong communication skills, regular training sessions, and close collaboration with cross-functional departments. Implementing robust reporting systems and conducting frequent internal audits also help in proactively identifying and mitigating risks, ensuring organizational compliance and excellence.

What is the difference between Director Of Quality And Risk vs Quality Assurance Manager?

AspectDirector Of Quality And RiskQuality Assurance Manager
CertificationsISO 9001 Lead Auditor, CQEASQ certifications, Six Sigma
Work EnvironmentStrategic, cross-departmental, executive levelOperational, team-focused, project management
Industry UsageHealthcare, manufacturing, corporate risk managementManufacturing, software, product development
Search & ComparisonOften compared for leadership roles overseeing quality and riskCompared for quality process improvements and compliance

The Director Of Quality And Risk typically holds a strategic leadership role overseeing quality assurance and risk management at an organizational level, often requiring advanced certifications. The Quality Assurance Manager focuses on operational quality processes within specific projects or departments. Both roles are essential in maintaining standards but differ in scope and responsibilities.

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Director Of Quality And Risk jobs near you
Director of Quality

Director of Quality

Elucent Medical, Inc.

Eden Prairie, MN • On-site

$155K - $170K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 5 days ago

Job description

Job Title:
Director of Quality

Department:
Quality

Reports to:
Chief Development and Compliance Officer

Work Location:
In-person (Eden Prairie, MN)

Pay Range:
$155,000-$170,000

Position Type and Expected Hours of Work:
Full-Time, Monday-Friday, 40 hours/week

About Elucent Medical:
Elucent Medical is a medical device company focused on developing surgical navigation technologies, particularly for cancer surgery, to improve patient outcomes through precision and efficacy. The company's solutions are designed to transform traditional surgical instruments into "smart" tools, enhancing surgical precision and patient outcomes.

Job Summary:
The Director, Quality owns two integrated areas of accountability: Elucent's Quality Management System (QMS) and product quality performance. This role provides strategic direction and hands-on leadership to ensure Elucent's products are safe, reliable, effective, and compliant across the full product lifecycle.
Responsibilities include QMS implementation and continuous improvement in accordance with 21 CFR Part 820, ISO 13485, ISO 14971, and applicable global standards, as well as product quality leadership across design assurance, manufacturing quality, supplier quality, complaint handling, CAPA, and post-market surveillance. The Director identifies and mitigates quality and compliance risks, leads quality planning for company growth, and maintains audit and inspection readiness.
As a strategic partner to executive leadership, the Director builds a high-performing quality organization and embeds quality practices into R amp;D, Operations, Supply Chain, Regulatory, and Commercial workflows.

Supervisory Responsibilities:
  • Recruit, hire, and train quality team members across quality systems and product quality functions.
  • Mentor and develop staff, providing career growth opportunities and building depth within the function.
  • Manage daily priorities, workload, and performance for the quality team.
  • Provide timely feedback, coaching, and performance evaluations.

Job Responsibilities:
Product Quality and Design Assurance:
  • Owns product quality outcomes and metrics across design and development, manufacturing, distribution, and post-market surveillance.
  • Oversees and/or Leads design assurance with R amp;D, including design controls, design reviews, V amp;V planning and execution, design transfer, risk management, and technical documentation compliance.
  • Partners with Operations to ensure production and process controls, process validation, manufacturing quality, and release activities meet regulatory and product requirements.
  • Oversees supplier qualification, monitoring, performance management, and supplier audit programs to ensure requirements are met from sourced materials through finished goods.
  • Uses customer feedback, complaints, nonconformances, CAPA outcomes, and post-market surveillance data to identify trends and drive systemic improvements.
  • Ensures customer, regulatory, and product quality requirements are defined, verified, and maintained across design, manufacturing, suppliers, and service operations.
Quality Systems amp; Compliance
  • Owns and continuously improves the QMS in accordance with 21 CFR Part 820, ISO 13485, ISO 14971, and applicable global standards, including MDSAP and EU MDR as appropriate.
  • Serves as Quality Management Representative, maintains inspection readiness, and leads FDA, Notified Body, customer, supplier, and internal audits.
  • Oversees CAPA, nonconforming materials, complaint handling, document control, change control, supplier quality system processes, and internal audits.
  • Ensures risk management processes are effectively embedded throughout the product lifecycle.
  • Leads eQMS enhancements, process optimization, and quality system continuous improvement initiatives.
  • Ensures policies, procedures, and departmental responsibilities align with company strategy and regulatory expectations.
Quality Leadership amp; Culture
  • Defines, analyzes, and reports QMS and product quality metrics to support data-driven decisions and executive-level visibility.
  • Provides training, tools, and cross-functional guidance to strengthen quality ownership and compliance across the organization.
Qualifications
Education and Experience:
  • Bachelor's degree in life science, engineering, or a related technical field required; advanced degree preferred.
  • 10+ years of progressive quality experience in the FDA-regulated medical device industry, with demonstrated leadership across both QMS and product quality functions.
  • 8+ years of experience managing, developing, and scaling quality teams.
  • Expert knowledge of medical device QMS and regulatory requirements, including 21 CFR Part 820, ISO 13485, ISO 14971, and applicable global requirements.
  • Hands-on experience owning product quality outcomes across design assurance, supplier quality, manufacturing quality, complaint handling, CAPA, and post-market surveillance.
  • Experience overseeing CAPA, nonconformances, internal and external audits, change control, document control, and supplier quality programs.
  • Proven ability to serve as Quality Management Representative and lead FDA, Notified Body, customer, and supplier audits.
  • Strong analytical and data-driven decision-making skills; familiarity with statistical methods including trend analysis.
  • Proficiency with modern eQMS tools and quality system software.
  • Hands-on leadership style with the ability to operate strategically while maintaining operational oversight of QMS and product quality activities.
  • Strong organizational, project management, prioritization, and follow-through skills.

Required Skills/Abilities:
Leadership amp; Strategy:
  • Provides strategic leadership for QMS and product quality functions, ensuring systems, processes, and product outcomes are integrated and mutually reinforcing.
  • Serves as the organizational subject matter expert for quality system requirements, product quality standards, and risk-based quality decisions.
  • Develops and mentors high-performing quality and compliance teams to support company growth and market expansion.
  • Aligns R amp;D, Operations, Supply Chain, Regulatory, and Commercial stakeholders around quality compliance and product quality performance throughout the lifecycle.
Communication
  • Demonstrates excellent written and verbal communication skills, including regulatory and audit responses and executive-level quality metrics presentations.
  • Communicates quality system requirements and product quality expectations clearly and effectively across all levels of the organization.
  • Provides training, coaching, and guidance to build a culture of compliance, quality ownership, and continuous improvement

Physical Requirements / Work Conditions:
  • Travel: 10%
  • Prolonged periods of sitting at a desk and working on a computer.
  • Must be able to lift up to 25 pounds at times.
  • Office and manufacturing floor environments

Elucent Medical Benefits, Culture and Work Environment
At Elucent Medical, we prioritize our employees' well-being by providing comprehensive benefits including comprehensive health insurance, a generous retirement savings plan with company matching, flexible work arrangements, generous paid time off, and ongoing professional development opportunities, ensuring a fulfilling and balanced work life.

Fulltime Employees are provided:
401(k)
401(k) matching (4%)
Dental insurance
Health insurance
Vision insurance
Paid Holidays
Paid Vacation Days
Paid Sick Days
Short Term Disability
Long Term Disability
Life Insurance
Pet Insurance
Employee Assistance Programs

Affirmative Action / EEO Statement
Elucent Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

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