Sr Quality Manager
Lexington, KY · Remote
Conduct on-site and remote GMP audits evaluating quality systems, documentation practices ... ASQ certifications such as CQA, CQM, CQE, or equivalent. * Experience supporting high-growth ...
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Sr Quality Manager
Lexington, KY · Remote
Conduct on-site and remote GMP audits evaluating quality systems, documentation practices ... ASQ certifications such as CQA, CQM, CQE, or equivalent. * Experience supporting high-growth ...
Cqe Remote information
What are the key skills and qualifications needed to thrive as a CQE remote, and why are they important?
To thrive as a remote CQE, you need a solid background in quality engineering principles, statistical analysis, and process improvement, usually supported by a degree in engineering or a related field and CQE certification. Familiarity with quality management systems (like ISO 9001), statistical software (such as Minitab), and virtual collaboration tools is also essential. Strong communication, self-motivation, and problem-solving skills help remote CQEs effectively coordinate with distributed teams and address quality issues proactively. These skills ensure consistent product quality, regulatory compliance, and smooth team collaboration, even when working remotely.
What is the difference between Cqe Remote vs Cqa Remote?
| Aspect | Cqe Remote | Cqa Remote |
|---|---|---|
| Certifications | ISO 9001, Six Sigma, CQE | ISO 9001, Six Sigma, CQA |
| Work Environment | Quality assurance, process improvement | Quality assurance, auditing |
| Industry Usage | Manufacturing, aerospace, automotive | Manufacturing, pharmaceuticals, food industry |
The main difference between Cqe Remote and Cqa Remote lies in their focus areas. Cqe Remote (Certified Quality Engineer) emphasizes quality engineering and process improvement, while Cqa Remote (Certified Quality Auditor) centers on auditing and compliance. Both roles require similar certifications and are used across various industries, but their core responsibilities differ, making each suitable for different career paths within quality management.
What is a CQE remote?
A CQE Remote typically refers to a Certified Quality Engineer (CQE) who works remotely rather than on-site. CQEs are professionals responsible for ensuring product and process quality in manufacturing or service industries, using statistical methods and quality management systems. Working remotely, they leverage digital tools to monitor quality processes, conduct audits, analyze data, and collaborate with teams virtually. This setup allows companies to access specialized quality expertise regardless of location, while offering CQEs flexibility and the ability to work from anywhere.
What are some common challenges faced by a remote Customer Quality Engineer (CQE), and how can they be effectively addressed?
As a remote CQE, one of the primary challenges is maintaining clear and consistent communication with cross-functional teams, as much of the work involves collaborating with engineering, manufacturing, and customer support teams to resolve quality issues. To address this, successful remote CQEs utilize scheduled video calls, detailed documentation, and collaborative platforms to ensure alignment and transparency. Additionally, staying proactive in tracking customer feedback and quality metrics helps prevent issues from escalating. Effective time management and self-motivation are also crucial for balancing multiple projects in a remote environment.
What are the most commonly searched types of Cqe jobs in Kentucky? The most popular types of Cqe jobs in Kentucky are:
What job categories do people searching Cqe Remote jobs in Kentucky look for? The top searched job categories for Cqe Remote jobs in Kentucky are:
What cities in Kentucky are hiring for Cqe Remote jobs? Cities in Kentucky with the most Cqe Remote job openings:
Job description
About the Company
Our client is a rapidly growing consumer health and wellness company that has quickly become a category leader in functional oral pouch products. Backed by top-tier consumer investors, industry operators, and professional athletes, the company is redefining performance-focused products through science-backed innovation and premium quality standards.
This is a unique opportunity to join a high-growth organization during a pivotal stage of expansion and help build the quality infrastructure that will support future growth.
Position Summary
The Senior Quality Manager will lead quality systems across the entire supply chain, from raw material suppliers and contract manufacturers to distribution and consumer complaint management.
This is a highly visible "build" role responsible for establishing and scaling quality processes, supplier qualification programs, audit systems, and complaint management procedures that ensure compliance with 21 CFR Part 111 and applicable dietary supplement regulations.
Reporting directly to executive leadership, this individual will serve as the quality subject matter expert and play a critical role in protecting product integrity, regulatory compliance, and consumer trust.
Key Responsibilities
Quality Systems & Compliance
- Maintain and continuously improve the Quality Management System (QMS), including SOPs, specifications, batch records, deviations, CAPA, and change control processes.
- Ensure compliance with 21 CFR Part 111 and applicable dietary supplement regulations.
- Partner with Product Development and Operations on specifications, stability programs, and product release testing.
- Drive a culture of continuous improvement and quality excellence.
Contract Manufacturer Audits
- Develop and execute a risk-based audit program across all manufacturing partners.
- Conduct on-site and remote GMP audits evaluating quality systems, documentation practices, sanitation programs, and manufacturing controls.
- Issue audit reports, track CAPAs, and verify timely closure of findings.
- Maintain audit readiness across all operational facilities.
Consumer Complaint Management
- Build and manage an end-to-end complaint handling system.
- Establish investigation workflows, escalation procedures, and adverse event reporting processes.
- Lead root cause investigations and CAPA implementation.
- Monitor complaint trends and provide actionable insights to Quality, Regulatory, and Product Development teams.
Supplier Qualification
- Develop and manage supplier qualification and approval programs.
- Review specifications, Certificates of Analysis, identity testing requirements, and supplier documentation.
- Conduct supplier risk assessments and maintain Approved Supplier Lists.
- Manage supplier performance monitoring, requalification activities, and change control processes.
Qualifications
Required
- Bachelor's degree in Chemistry, Food Science, Microbiology, or related scientific discipline.
- 5+ years of quality experience within dietary supplements, food, pharmaceuticals, or consumer products.
- Experience leading or supporting supplier qualification programs and GMP audit initiatives.
- Strong working knowledge of:
- 21 CFR Part 111
- GMP requirements
- CAPA systems
- Complaint handling processes
- Supplier quality management
- Experience implementing or managing quality tracking and complaint management systems.
- Strong investigative, problem-solving, and root-cause analysis skills.
Preferred
- Experience with oral pouch, buccal, or alternative delivery systems.
- ASQ certifications such as CQA, CQM, CQE, or equivalent.
- Experience supporting high-growth consumer products or dietary supplement organizations.
About Keystone & Golden, Inc. Recruiters for the Nutraceutical Industry
Sourced by ZipRecruiter
Industry
Fitness and sports centers
Company size
1 - 10 Employees
Headquarters location
San Diego, CA, US
Year founded
2016