Director of Quality Systems – ISO Excellence in Manufacturing

Are you a quality-driven leader with a passion for continuous improvement and regulatory compliance? We are seeking a Director of Quality Systems to oversee quality assurance and control across multiple ISO-certified manufacturing facilities in Miami, FL. This is a pivotal role for a seasoned professional who thrives in structured environments and is committed to delivering world-class quality in production systems.

Champion Quality Across ISO-Certified Plants in Miami

A leading manufacturing organization in Miami, FL is hiring a Director of Quality Systems to elevate and maintain the integrity of its ISO-certified operations. The ideal candidate will have a deep understanding of ISO 9001/13485 standards, regulatory requirements, and quality system frameworks. This executive will be responsible for implementing robust quality management systems, leading audits, and driving a culture of excellence across the plant network.

Key Responsibilities of the Director of Quality Systems – ISO-Certified Plants

Quality System Leadership:
Develop, implement, and oversee robust Quality Management Systems (QMS) across multiple ISO-certified manufacturing sites. Ensure alignment with ISO 9001, ISO 13485, and other relevant regulatory frameworks to maintain world-class quality standards.

Audit & Compliance Management:
Lead internal and external audits, including ISO certification and customer audits. Ensure all facilities maintain audit readiness and full compliance with federal, state, and industry-specific regulatory requirements.

Process Improvement & Standardization:
Drive continuous improvement initiatives to optimize quality processes, reduce defects, and improve product consistency. Implement standard operating procedures (SOPs) and corrective/preventive actions (CAPAs) to support operational excellence.

Cross-Functional Collaboration:
Work closely with operations, engineering, R&D, and supply chain teams to embed quality into every stage of production. Facilitate cross-functional efforts to resolve quality issues and ensure root-cause analysis and long-term corrective actions are effective.

Training & Team Development:
Build and lead a high-performing quality team. Provide training on quality standards, GMP practices, and compliance protocols. Foster a culture of accountability, continuous learning, and quality ownership throughout the organization.

Risk Management & Product Integrity:
Identify quality-related risks across the product lifecycle and implement proactive risk mitigation strategies. Ensure all products meet customer specifications, industry standards, and internal benchmarks for quality and safety.

Data-Driven Decision Making:
Utilize metrics and KPIs to monitor quality performance, analyze trends, and report outcomes to executive leadership. Leverage quality data to guide improvements and inform strategic decisions.

Supplier Quality Assurance:
Establish and manage supplier quality programs, including qualification, audits, and performance monitoring. Partner with procurement and operations to maintain strong supplier relationships and ensure incoming materials meet quality standards.

Customer Focus & Complaint Resolution:
Oversee customer feedback and complaint handling systems to ensure timely resolution and continuous improvement. Maintain high levels of customer satisfaction through effective quality support and communication.

Regulatory Affairs Alignment:
Collaborate with regulatory teams to support product registrations, submissions, and compliance with FDA, ISO, and other applicable regulations. Ensure documentation practices and QMS protocols meet audit and submission standards.

What the Client is Looking for in You

As the Director of Quality Systems, the client seeks an experienced quality leader with a deep understanding of ISO-certified manufacturing environments and a commitment to operational excellence. You should be detail-oriented, compliance-driven, and capable of leading cross-functional quality initiatives across multiple facilities. If you thrive in fast-paced, process-focused settings and excel at continuous improvement, this role is built for you.

Extensive Experience in Quality Leadership

The client is seeking a quality systems professional with a solid background in leading QMS across ISO 9001/13485-certified plants. You should have hands-on experience in implementing and maintaining ISO standards, managing audits, and driving corrective/preventive actions. A history of maintaining regulatory compliance in highly regulated industries such as medical devices, food production, or industrial manufacturing is highly desirable.

Operational and Regulatory Expertise

You should possess strong knowledge of FDA regulations, GMP, CAPA systems, and risk management protocols. The ideal candidate will be proficient in evaluating and improving quality procedures, leading cross-departmental investigations, and ensuring audit readiness at all times.

Strategic and Analytical Mindset

The client is looking for a systems thinker who can translate data into meaningful insights. You should be able to lead quality performance reviews, generate actionable KPIs, and use analytics to guide improvements in process efficiency, product integrity, and customer satisfaction.

Proven Leadership and Team Development

As Director, you will be expected to lead and mentor a team of quality professionals. The client values candidates who foster a culture of accountability, training, and professional growth, and who can drive engagement through clear communication, leadership by example, and a shared vision for quality excellence.

Strong Communication and Collaboration Skills

You should excel at working with both internal teams and external stakeholders, including auditors, suppliers, and regulatory agencies. The client seeks someone with excellent interpersonal skills who can build alignment, advocate for quality at the executive level, and guide teams through complex change initiatives.

Customer-Focused and Compliance-Driven

The ability to handle customer complaints, ensure product compliance, and drive quality-related customer satisfaction is essential. The ideal candidate will approach quality with a customer-first mindset, ensuring products meet expectations while maintaining full regulatory and safety compliance.

Commitment to Continuous Improvement

The client highly values professionals who are passionate about Lean, Six Sigma, or Kaizen methodologies and who can demonstrate measurable success in improving process performance, reducing defects, and enhancing overall product quality.

FAQs About the Role – Director of Quality Systems – ISO-Certified Plants

1. What are the key responsibilities of the Director of Quality Systems in this role?
As the Director of Quality Systems, you will oversee the quality management systems (QMS) across multiple ISO-certified manufacturing sites. Your responsibilities include ensuring regulatory compliance, managing internal and external audits, leading CAPA initiatives, driving continuous improvement, and ensuring product and process quality. You will also collaborate cross-functionally to maintain operational excellence and a culture of quality throughout the organization.

2. What qualifications and experience are required for this position?
The ideal candidate should have a strong background in quality management within regulated industries such as medical devices, pharmaceuticals, food production, or industrial manufacturing. A minimum of 8–10 years of experience in leading QMS and ISO 9001/13485-certified environments is required. Experience with FDA regulations, GMP, and managing quality teams is essential. Certifications such as Six Sigma, ASQ, or lead auditor credentials are highly valued.

3. What leadership qualities are essential for this role?
The client seeks a proactive, detail-oriented leader with a strategic mindset and strong problem-solving skills. You should demonstrate the ability to mentor teams, communicate effectively across departments, and instill a culture of accountability and continuous improvement. The ability to lead through influence and align quality goals with broader business objectives is critical.

4. What challenges can I expect in this role?
This role involves managing quality across multiple ISO-certified facilities, each with unique compliance requirements and operational nuances. You may face challenges such as harmonizing QMS across locations, improving audit readiness, reducing non-conformities, and addressing complex CAPAs. Ensuring ongoing regulatory compliance and navigating cross-functional collaboration in a fast-paced environment are key components of the role.

5. How does this role impact the company’s operations and success?
As Director of Quality Systems, you will be instrumental in ensuring product safety, compliance, and customer satisfaction. Your leadership will directly impact operational efficiency, brand reputation, and risk mitigation. By optimizing quality processes and aligning them with the company’s strategic goals, you will play a crucial role in driving business success and maintaining industry certifications.

6. What is the company’s culture and work environment like?
The company promotes a collaborative, high-integrity, and innovation-focused environment. Quality is a shared responsibility, and leadership encourages open communication, employee development, and cross-functional teamwork. You’ll be joining an organization that values continuous improvement, transparency, and operational excellence across all levels.

What Remuneration Can You Expect from This Job?

As the Director of Quality Systems for ISO-certified manufacturing plants based in Miami, FL, you can expect a competitive compensation package that reflects your leadership responsibilities, technical expertise, and ability to drive regulatory and operational excellence. The package typically includes the following components:

1. Base Salary
The base salary for a Director of Quality Systems in a regulated manufacturing environment generally ranges between $130,000 and $180,000 per year, depending on the size and complexity of the organization, as well as the candidate’s experience and certifications.

2. Performance-Based Bonuses
Annual bonuses are often tied to personal KPIs and company-wide metrics such as audit success rates, compliance scores, cost savings through quality improvements, and team performance. These bonuses typically range from 10% to 25% of the base salary.

3. Long-Term Incentives
Depending on the organization, the role may also include long-term incentive plans (LTIPs) such as deferred cash bonuses or equity participation (especially in private equity-backed or rapidly scaling firms). These incentives reward sustained high performance and leadership.

4. Benefits & Perks
The benefits package typically includes:

Comprehensive health, dental, and vision insurance
401(k) plans with employer match
Paid time off, holidays, and parental leave
Continuing education and certification reimbursements
On-site wellness programs or stipends for health initiatives
Travel reimbursements if the role requires visiting multiple facilities

5. Relocation Assistance & Signing Bonus
If relocation is required, companies may offer relocation support packages, which can include moving expenses, temporary housing, or a signing bonus—usually ranging from $10,000 to $25,000.

Total Compensation Potential

When combining base pay, performance bonuses, and benefits, the total annual compensation for this role typically falls in the $150,000 to $230,000 range. In companies with aggressive growth or strict regulatory demands, the package may exceed this range to attract top talent.

How to Apply

If you are an accomplished quality systems leader with deep expertise in ISO-certified manufacturing environments, we invite you to apply for the Director of Quality Systems role based in Miami, FL. This is a high-impact leadership position where your ability to maintain compliance, drive continuous improvement, and lead cross-functional quality initiatives will be instrumental in the company’s ongoing success.

To apply, please submit your updated resume along with a cover letter outlining your experience in quality assurance, regulatory compliance, audit readiness, risk mitigation, team leadership, and implementation of ISO standards (such as ISO 9001, ISO 13485, or ISO 22000). Be sure to include examples of successful audit outcomes, system improvements, and how you’ve built a culture of quality in your previous roles.

This is an opportunity to contribute to a mission-driven organization where operational excellence, innovation, and compliance intersect. Apply today to become a key driver of quality and regulatory success as the Director of Quality Systems – ISO-Certified Plants in Miami, FL.

For more information or to explore similar roles in quality leadership, visit our Manufacturing & Quality Executive Search page.

Job Category: ISO-Certified Plants

Job Type: Full Time

Job Location: Miami

Director of Quality Systems – Miami, FL | ISO-Certified Plants