Virtual Quality Standards Specialist
Annual Salary: USD 58,035
Job Type: Full-time, Remote
Location: Virtual/Remote

Job Overview:

The Virtual Quality Standards Specialist ensures that the products, services, and processes meet established quality standards and comply with all relevant regulatory requirements. This remote role oversees quality management systems, conducts audits, analyzes data, and provides guidance on continuous improvement initiatives. The ideal candidate will possess a strong background in quality assurance, a keen eye for detail, and the ability to work independently while effectively collaborating with cross-functional teams.

Key Responsibilities:

1. Quality Management System (QMS) Oversight:

• Develop, implement, and maintain a comprehensive Quality Management System (QMS) that aligns with industry standards and best practices.
• Ensure all processes, procedures, and work instructions are documented, up-to-date, and accessible to relevant personnel.
• Monitor the effectiveness of the QMS and recommend improvements based on data-driven insights and stakeholder feedback.
• Ensure compliance with applicable regulatory requirements, including ISO standards, FDA regulations, and other industry-specific guidelines.

2. Auditing and Compliance:

• Plan, schedule, and conduct internal audits to assess compliance with established quality standards and identify areas for improvement.
• Coordinate external audits with regulatory agencies, customers, and third-party auditors.
• Prepare detailed audit reports, including findings, root cause analysis, and corrective action plans.
• Track and verify the implementation of corrective and preventive actions (CAPAs) to ensure timely resolution of identified issues.
• Maintain accurate records of all audits, inspections, and compliance activities.

3. Continuous Improvement Initiatives:

• Lead continuous improvement projects to enhance product quality, process efficiency, and customer satisfaction.
• Collaborate with cross-functional teams, including production, engineering, procurement, and customer service, to identify opportunities for process optimization.
• Analyze quality data and trends to identify root causes of defects and non-conformances.
• Develop and implement solutions to eliminate waste, reduce variability, and enhance overall product and service quality.
• Facilitate training sessions and workshops to promote a culture of continuous improvement and quality excellence across the organization.

4. Product and Process Quality Assurance:

• Conduct thorough reviews of product designs, specifications, and manufacturing processes to ensure they meet quality and regulatory requirements.
• Perform risk assessments and develop mitigation strategies to address potential quality and safety issues.
• I oversee the inspection and testing of incoming materials, in-process products, and finished goods to verify their conformance to specifications.
• Collaborate with suppliers and vendors to ensure the quality of purchased materials and components.
• Develop and maintain quality metrics and performance indicators to monitor and report on product quality.

5. Customer and Stakeholder Engagement:

• Serve as the primary point of contact for quality-related inquiries and concerns from customers, suppliers, and internal stakeholders.
• Investigate and resolve customer complaints and issues related to product quality.
• Provide technical support and guidance to customers on quality-related matters.
• Prepared and delivered presentations and reports on quality performance to senior management and key stakeholders.
• Build and maintain strong relationships with customers, suppliers, and regulatory agencies to ensure effective communication and collaboration on quality matters.

Qualifications and Skills:

Education:

• A bachelor's degree in Quality Assurance, Engineering, or a related field is required, but a master's degree is preferred.
• Professional certifications such as Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Six Sigma Green/Black Belt are highly desirable.

Experience:

• At least 5 years of experience in quality assurance, quality control, or a related field, preferably in a virtual or remote work environment.
• Demonstrated experience in developing, implementing, and managing Quality Management Systems (QMS).
• Strong knowledge of ISO standards, FDA regulations, and other relevant quality standards and guidelines.

Skills:

• Excellent analytical and problem-solving skills, with the ability to identify root causes and develop practical solutions.
• Strong attention to detail and a commitment to accuracy and precision.
• Proficient in quality management software, data analysis tools, and Microsoft Office Suite (Excel, Word, PowerPoint).
• Strong communication and interpersonal skills, with the ability to collaborate effectively with diverse teams and stakeholders.
• Self-motivated and capable of working independently with minimal supervision.
• Strong organizational and time management skills, with the ability to prioritize tasks and manage multiple projects simultaneously.

Work Environment:

• This fully remote position offers flexibility in work location and hours. However, candidates must be available to participate in virtual meetings and collaborate with team members across different time zones as required.
• The role may require occasional travel for audits, inspections, and meetings with customers or suppliers.

Career Development:

• Opportunities for professional growth and advancement within the organization.
• Access to continuous learning and development programs, including certifications and training in advanced quality management methodologies.

Application Process:

• Candidates must undergo a background check and provide references upon request.
• The selection process may include multiple rounds of interviews, including technical assessments and case studies.

This position offers a competitive salary of USD 58,035 and a comprehensive benefits package that includes health insurance, retirement savings plans, and paid time off. The Virtual Quality Standards Specialist role is ideal for a detail-oriented professional with a passion for quality and a desire to contribute to the success of a dynamic and innovative organization.