Senior Quality Specialist

1 month ago

Manassas, United States Notal Vision Full time

We are looking for an experienced quality assurance specialist to join our QA global group.


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 will lead the quality activities in the US site.

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, MDR 2017/745 etc.).

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:

  • Quality inspection from incoming to release of product/ spare parts before distribution.
  • Complaint Handling -support in problems investigation process, lead CAPA process.
  • Non-conforming material and product handling
  • Calibration and equipment periodical inspection follow up
  • Training of personnel
  • Performing internal inspections and reviews to ensure employees adhere to quality and safety policies.
  • Supplier qualification
  • Follow up ECO implementation.
  • Quality records review, retention, and archiving
  • 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.

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.

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