Quality Assurance Specialist

5 days 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.

About the Role:

The ideal candidate will possess a strong familiarity with ISO 13485 standards, ensuring the highest quality in our products and processes. You will be responsible for conducting product validation lab testing, data analysis, and report writing. Additionally, you will perform inspections and tests on incoming materials, document findings, and manage sorting and rework.

Key Responsibilities:

  • Conduct product validation lab testing, data analysis, and report writing.
  • Perform inspections and tests on incoming materials, document findings, and manage sorting and rework.
  • Monitor product quality throughout production to ensure compliance with standards.
  • Accurately document inspection and testing results, maintaining quality assurance records.
  • Identify and report defects, recommend disposition, and communicate with relevant departments.
  • Assist in internal and external QMS audits, supporting QRM and auditors.
  • 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.
  • Generate and verify traceability information and QA documentation.
  • Collaborate with various departments on product and process regulatory requirements, including CAPAs.
  • Stay updated on trends and advances in device manufacturing and quality control.

Requirements:

  • Strong verbal and written communication, with teaching and training capabilities.
  • Proficiency in mathematics, statistics, and report writing.
  • Excellent organizational skills and attention to detail.
  • Ability to understand technical specifications.
  • Skilled with test and measurement equipment and documentation software.
  • Proficient in Microsoft Office Suite or similar software.

Education/Experience:

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

Compensation:

Base Salary range of $44 – 54 K (based on background) with bonus potential. 401K with profit sharing.

Health (Medical, Dental, Vision, HSA, FSA), Life, Short-term and Long-term disability, Accident and Critical Illness insurance

Professional development support through company-sponsored training and tuition reimbursement.

Whole health support with Employee Assistant Program (EAP), regular and volunteerism paid time off, hybrid work option, free on-site gym access and subsidized gym membership.

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