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Quality Assurance Specialist

1 month ago

Spring Lake, Michigan, United States Garrison Dental Solutions LLC Full time
Quality Technician Job Description

We are seeking a detail-oriented Quality Technician to join our dynamic team at Garrison Dental Solutions LLC. As a Quality Technician, you will play a pivotal role in maintaining excellence and driving innovation within our organization.

Key Responsibilities:

  • Conduct product validation lab testing, data analysis, and report writing to ensure compliance with quality standards.
  • Perform inspections and tests on incoming materials, document findings, and manage sorting and rework to maintain product quality.
  • Monitor product quality throughout production to ensure compliance with ISO 13485 standards and other regulations.
  • Accurately document inspection and testing results, maintaining quality assurance records and ensuring data integrity.
  • Identify and report defects, recommend disposition, and communicate with relevant departments to resolve quality issues.
  • Assist in internal and external QMS audits, supporting QRM and auditors to ensure compliance with quality standards.
  • Maintain and update QMS procedures and work instructions to comply with ISO 13485, MDSAP, FDA, and other regulations.
  • Provide employee training on quality standards, procedures, and best practices to ensure a culture of quality within the organization.
  • Generate and verify traceability information and QA documentation to ensure product integrity.
  • Collaborate with various departments on product and process regulatory requirements, including CAPAs, to ensure compliance with quality standards.

Requirements:

  • Strong verbal and written communication skills, with teaching and training capabilities.
  • Proficiency in mathematics, statistics, and report writing to analyze data and make informed decisions.
  • Excellent organizational skills and attention to detail to ensure accuracy and quality in all aspects of the job.
  • Ability to understand technical specifications and quality standards to ensure compliance.
  • Skilled with test and measurement equipment and documentation software to ensure accurate data collection and analysis.
  • Proficient in Microsoft Office Suite or similar software to create reports, documents, and presentations.

Education/Experience:

  • High school diploma or equivalent; associate degree/technical certification preferred.
  • Experience with Quality Management Systems, including ISO 13485, Six Sigma, or Lean Manufacturing.
  • Knowledge of quality standards and regulations, including FDA and MDSAP.
  • Preferred internal auditing experience and competence in Geometric Dimensioning & Tolerancing (GD&T).
  • Familiarity with continuous improvement tools, such as 5S, PDCA, Value Stream Mapping, and Six Sigma.

Compensation:

Base Salary range of $44,000 - $54,000 per year, with bonus potential and a competitive benefits package, including health, life, and disability insurance, 401(k) with profit sharing, and professional development support.