Quality Assurance Engineer

2 weeks ago

Ramsey, United States HOYA Vision Care Full time
Become a Part of HOYA Vision Care

With a legacy spanning over six decades, HOYA Vision Care stands at the forefront of innovation in optical technology. As a premier manufacturer of high-quality eyeglass lenses, we are dedicated to delivering exceptional vision care solutions to eye care professionals.

We are excited to announce an opening for a Quality Assurance Engineer.

What We Offer:
  • Comprehensive Health, Dental, and Vision Insurance
  • Tuition Assistance Programs
  • Retirement Savings Plans (401K)
  • Paid Time Off and Holidays
  • Additional Benefits
Your Responsibilities:
  • Collaborate with project management to ensure compliance with regulatory and quality standards for medical devices.
  • Engage with cross-functional teams to provide quality leadership and support in design control methodologies for medical device development.
  • Conduct thorough risk assessments and participate in design failure mode and effects analysis (DFMEA).
  • Create and maintain documentation (such as quality plans and procedures) to ensure adherence to relevant regulations.
  • Contribute to the development of product validation plans and assist in validation testing.
  • Support the Quality and Metrology Manager in maintaining and enhancing the Quality Management System (QMS).
  • Execute internal QMS audits to verify compliance with quality standards.
  • Assist the Quality Manager during external audits (including ISO 9001, ISO 13485, and FDA audits).
  • Investigate non-compliance issues, identify root causes, and formulate corrective and preventive actions.
Qualifications:
  • Bachelor's degree in Engineering, Science, or a related discipline.
  • A minimum of 2 years of practical experience in medical device quality engineering.
  • Familiarity with FDA-regulated products and ISO 13485 certified Quality Management Systems.
  • Experience in product development with a focus on implementing effective controls.
  • Proficient in statistical analysis, with Six Sigma Green Belt certification being advantageous.
  • Solid understanding of FDA regulations (21 CFR 820) and other pertinent standards is highly preferred.
  • Experience in conducting QMS audits is preferred, with ASQ certification as a Quality Auditor being a plus.
  • Experience in a medical device start-up environment is beneficial.
  • Knowledge of risk management tools, design controls, and process validation (IQ/OQ/PQ) is advantageous.
  • Experience in optics or ophthalmic fields is a plus.
  • Proficient in Minitab, MS Outlook, MS Word, and MS Excel.
Additional Information:
  • Compensation Type: Salary

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