POSITION SUMMARY:

Reporting to Notal Vision’s Manager, Quality Management, the Quality Associate assists management to maintain the Quality Management System (QMS) in compliance with applicable standards and regulatory requirements. The Quality Associate outlines quality standards and develops quality control processes including, but are not limited to, inspecting materials, processes, products, and ensuring compliance with new and existing quality standards and regulations (i.e., 21 CFR 820, ISO 13485, etc.).

The Quality Associate assists with implementing quality management actions and reporting in support of the organization. The successful Quality Associate should ensure all materials, processes, and procedures meet regulatory and quality standards, in addition to promptly resolving any issues or discrepancies that may arise.

ROLE AND RESPONSIBILITIES:

Document Management

• Monitoring and reporting on all activities, processes, and procedures.
• Ensuring compliance with current regulations, to include 21 CFR 820.
• Assisting with the development of company policies, processes, and procedures.
• Preparing and maintaining quality management documentation.
• Developing and implementing Policies and Procedures, including retention and disposal or records and support the document management system to operate effectively.
• Contributing to the maintenance of SOPs in support of the strategic, quality, and continuous improvement agenda of the company.
• Identifies Root Cause by utilizing common and advanced root cause analysis tools such as, FMEA, Fishbone and 5 whys.

Process and Management of Quality Records / Auditing

• Assisting with developing internal auditing tools and conducting internal audits and reports.
• Determining data-driven solutions and implementing quality improvement plans.
• Performing regular inspections and reviews to ensure employees adhere to quality and safety policies.
• Coordinating incoming complaints including reviewing complaints with the appropriate department for investigation and resolution.
• Developing tools and resources to contribute to the efficiency in investigating and closing complaints.
• Identifying areas for process improvement in quality management. departmental training.
• Conducting and assisting with regulatory and quality training sessions.
• Providing departments with quality planning and support. · Facilitate meetings and workshops focusing on the development of staff and the company’s overall quality management initiatives.

Reporting

• In coordination with Manager, create trend analysis reporting for all quality management initiatives.
• Develop opportunities for improvement from departmental reporting.
• Report findings and outcomes related to quality management issues immediately to management.
• Coordinate communications regarding other regulated company topics, such as HIPAA, as needed

Other Organizational Responsibilities

• Other duties, consistent with skills and experience, as directed by the reporting manager.EXPERIENCE AND EDUCATION REQUIREMENTS:
• Bachelor’s degree in relevant field or equivalent experience/training, preferred.
• 1-2 years of relevant experience working with quality systems.
• Experience managing multiple complex projects simultaneously.
• Experience working in a team-oriented, collaborative environment.
• Working knowledge of quality system requirements including 21 CFR 820 and ISO 13485.
• Experience with MS Word, Excel, Project Management and Analytics software.
• Willingness to pursue and attain certification in quality management.
• Strong knowledge of GMP regulations and ability to apply them to commercial manufacturing.
• Knowledge and understanding of Root Cause Analysis process in a regulated environment.

Key Skills / Abilities / Traits

• Excellent communication, interpersonal, and public speaking skills.
• Excellent decision-making and problem-solving skills.
• Strong attention to detail and exceptional organizational skills.
• Excellent verbal and written communication skills, including the ability to effectively interact with employees at all levels within and across the organization.
• Energetic, forward-thinking, and creative with high ethical standards.
• Highly self-motivated and self-directed.
• Ability to prioritize and perform within a deadline structured environment.
• Handling multiple tasks and demands in a fast-paced, highly collaborative work environment.

Job Type: Full-time

Pay: From $54,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Day shift
• Monday to Friday

Supplemental pay types:

• Bonus opportunities

Education:

• Bachelor's (Preferred)

Experience:

• Quality management: 2 years (Required)
• managing multiple complex projects: 2 years (Required)

Work Location: In person