Quality Assurance Manager

6 hours ago

Menomonee Falls, Wisconsin, United States Argus Technical Services Full time
Job Title: Quality Manager

Argus Technical Services is seeking a highly skilled Quality Manager to join our team. The successful candidate will be responsible for developing and implementing a comprehensive quality management system to ensure consistent product quality and compliance with regulatory and ISO standards.

Key Responsibilities:
  • Develop and implement quality standards for products and processes to prevent defects and ensure compliance with regulatory and ISO standards.
  • Establish and maintain a quality management system that meets ISO 13485:2016 and 21 CFR 820 requirements.
  • Conduct audits and assessments to ensure quality standards are met and identify areas for improvement.
  • Develop and implement corrective actions to address quality issues and prevent recurrence.
  • Collaborate with cross-functional teams to develop and implement quality control plans and processes.
  • Provide training and support to employees on quality procedures and protocols.
  • Monitor and analyze quality metrics to identify trends and areas for improvement.
  • Develop and implement process improvements to enhance manufacturing processes, quality, and cost effectiveness.
Requirements:
  • College degree in a related field (e.g. quality assurance, engineering, business).
  • 5+ years of progressive quality experience in a manufacturing environment.
  • Experience with ISO 13485:2016 and 21 CFR 820 quality systems.
  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Proficiency in MS Office Suite and quality management software.
Preferred Qualifications:
  • Experience with FDA requirements and regulations.
  • Knowledge of label industry software (LabelTraxx).
  • Ability to interpret drawings and specifications.
Physical Demands and Work Environment:

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • Physical demands: While performing the duties of this job, the employee is frequently required to sit and talk or hear. The employee is occasionally required to stand, walk, and use hands to finger, handle, or feel. The employee must occasionally lift and/or move up to 30 pounds.
  • Work environment: The noise level in the working environment is normally quiet.

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