Director of Quality
Listed on 2026-10-10
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Quality Assurance - QA/QC
Regulatory Compliance Specialist -
Management
Regulatory Compliance Specialist
Key Responsibilities
- Develop and execute a comprehensive quality strategy aligned with organizational goals.
- Serve as a key member of the leadership team, advising on quality risks, compliance, and performance.
- Build and lead high-performing quality teams across multiple locations or business units.
- Promote a culture of quality, accountability, and continuous improvement.
- Oversee the design, implementation, and maintenance of the Quality Management System (e.g., ISO, FDA, or industry-specific standards).
- Ensure compliance with all applicable regulatory and certification requirements.
- Lead internal and external audits, inspections, and certifications.
- Establish and maintain quality policies, procedures, and documentation.
- Drive continuous improvement initiatives using Lean, Six Sigma, or similar methodologies.
- Analyze quality data and metrics to identify trends, root causes, and opportunities for improvement.
- Partner with Operations, Engineering, and Supply Chain to improve process efficiency and product quality.
- Lead corrective and preventive action (CAPA) processes.
- Ensure customer quality requirements and expectations are consistently met or exceeded.
- Oversee customer complaint resolution and root cause analysis.
- Manage supplier quality programs, including qualification, performance monitoring, and audits.
- Strengthen supplier partnerships to ensure consistent materials and service standards.
- Identify quality-related risks and implement mitigation strategies.
- Ensure compliance with all regulatory bodies and applicable laws.
- Maintain readiness for regulatory inspections and audits.
- Define and track key performance indicators (KPIs) for quality performance.
- Provide regular executive-level reporting on quality trends, risks, and improvements.
- Use data-driven insights to support strategic decision-making.
- Bachelor’s degree in Engineering, Quality Management, Life Sciences, or related field required.
- Master’s degree (MBA or technical discipline) preferred.
- 10+ years of progressive experience in quality management, including 5+ years in a leadership role.
- Experience in [insert industry: manufacturing, healthcare, biotech, food, etc.].
- Proven track record of implementing and improving QMS frameworks.
- Strong experience with regulatory and compliance standards (e.g., ISO 9001, FDA, GMP, etc.).
- ASQ Certified Quality Manager (CQM) or similar.
- Lean Six Sigma Black Belt or equivalent.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
RelocationRelocation is authorized for this position.
For informational purposes only, the range for annual base salary for this role is $170000 to $256000 US Dollar (USD) Salaried based on a variety of factors. For informational purposes only, this role is eligible to participate in the Company’s Executive Bonus Plan, paid out up to 25% of the applicable annual base salary, based on the Company’s performance in the prior calendar year.
Employees will receive 120 hours paid time off every year. Employees will also receive 10 paid holidays. Employees (and their families) are eligible to participate in the…
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