Quality Supervisor (Manufacturing)
Мэтч & Сопровод
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Описание вакансии
TL;DR
Quality Supervisor (Manufacturing): Leading quality operations and building the QA Testing Lab for an ISO 13485-certified optical manufacturing facility with an accent on test method development, regulatory compliance, and non-conformance management. Focus on establishing scalable testing capabilities, driving root cause investigations, and ensuring adherence to FDA and ISO standards.
Location: Onsite in Obetz, Ohio
Company
Global brand providing affordable prescription eyewear with a focus on innovation in optical products.
What you will do
- Lead the buildout and management of the QA Testing Lab, including equipment installation and test method validation.
- Develop and implement inspection processes for optical performance, coating durability, and surface quality.
- Manage the Breakage Department, overseeing the identification and disposition of nonconforming products.
- Plan and execute internal quality audits in alignment with ISO 13485 and support external FDA inspections.
- Maintain the Quality Management System (QMS) and manage the CAPA process for continuous improvement.
- Define and track quality KPIs, including test yield, scrap rates, and defect trends.
Requirements
- Bachelor's degree in Quality, Engineering, Manufacturing, or equivalent experience.
- 3–5+ years of quality experience in a manufacturing environment.
- Demonstrated experience in lab setup, process development, or test method implementation.
- Prior supervisory or leadership experience.
- Strong working knowledge of ISO 13485 and quality system requirements.
- Experience with CAPA, root cause analysis, and nonconforming product control.
Nice to have
- Experience in optical manufacturing (Rx lenses, coatings, surfacing, edging).
- Familiarity with FDA 21 CFR Part 820.
- Experience with equipment qualification (IQ/OQ/PQ) and validation.
- ASQ certification (CQE, CQA) or Lean/Six Sigma training.
Culture & Benefits
- Comprehensive health care plan (Medical, Dental, Vision) and Life Insurance.
- Retirement plan with 401K matching.
- Annual Bonus Program and Paid Time Off.
- Free daily lunch and Employee Assistance Program.
- Professional training and development opportunities.
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