Quality Specialist

2 weeks ago


Parma, United States LHH Full time

Quality Specialist

LHH is hiring a Quality Specialist for a leading OTC medical device company in Parma, OH area. Our client is looking for a highly motivated and detail-oriented Quality Specialist to join their dynamic team. The Quality Specialist will play a crucial role in ensuring the highest standards of quality and compliance for their products. This position involves close collaboration with various departments to maintain and improve our quality management systems and processes. If you have 3 years as a Quality Specialist working on regulatory and compliance for a medical device company. APPLY TODAY

Responsibilities:

  • Maintain and improve the Quality Management System in compliance with ISO 13485 and FDA regulations.
  • Ensure documentation is up-to-date and accurately reflects current practices.
  • Ensure products meet all applicable regulatory requirements, including FDA, ISO, and other relevant standards.
  • Prepare and review regulatory submissions and ensure timely filing and approval.
  • Conduct internal audits to ensure compliance with QMS and regulatory requirements.
  • Coordinate and support external audits and inspections from regulatory bodies.
  • Oversee and participate in product testing and validation to ensure compliance with quality standards.
  • Investigate and resolve quality issues, including customer complaints and non-conformances.
  • Identify opportunities for process improvement and implement changes to enhance product quality and efficiency.
  • Lead or participate in quality improvement projects and cross-functional teams.
  • Develop and conduct training programs for employees on quality standards and procedures.
  • Keep abreast of industry trends and best practices to ensure continuous improvement of the QMS.

Qualifications:

  • Bachelor’s degree in a related field (e.g., Quality Management, Engineering, Life Sciences).
  • Minimum of 3 years of experience in quality assurance within the medical device industry.
  • In-depth knowledge of ISO 13485, FDA regulations, and other relevant standards.
  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal skills.
  • Proficiency in quality management software and tools.
  • Ability to work independently and as part of a team.


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