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Quality Manager

HIGHPOWER Validation Testing & Lab Services
Rochester, NY Full Time
POSTED ON 12/15/2024
AVAILABLE BEFORE 2/10/2025

Quality Manager for Testing Laboratory 

HIGHPOWER Validation Testing & Lab Services, Inc., a Henrietta NY based validation laboratory is looking for a full time Quality Manager to manage and improve our existing ISO 17025 quality system and to support compliance for a small growing laboratory. Candidate should be energetic, hard-working, and knowledgeable in either ISO 17025, 13485, 9001 or FDA/GMP Quality systems. The ideal candidate should have attention to detail, excellent customer skills, and experience working in a regulated environment. The chosen candidate will work directly for the company’s General Manager. Responsibilities include but are not limited to:


  • Implementing corrective and preventive actions
  • Investing complaints and out of specification (O.O.S) results
  • Perform internal and external audits
  • Maintenance of documents within the quality management system
  • QA process review of completed studies and raw data
  • Maintenance of ISO Certifications/Accreditations
  • Maintaining the company Quality Manual
  • Performing supplier and service provider assessments
  • Provide quality system training to employees
  • Implementing process improvement quality initiatives
  • Assisting Executive Management as required  


The position is an in-office position with general working hours of 7:30 am to 4:00pm, Monday through Friday. 


Skills Required: Excellent written and oral communication skills, computer literate, and proficient in Microsoft Word, Microsoft Excel, Adobe, and Smartsheet a plus. Knowledge and work experience in ISO 17025, 13485, 9001 or FDA/GMP Quality systems is a necessity.  Must be well organized and able to pick up tasks quickly, be a team player, and able to multi-task in a busy laboratory environment. 


Employee benefits include:

Competitive Salary along with Medical, Dental and Vision Insurance, 401(k) plan with match, Christmas Bonus, Vacation & PTO/Sick Leave along with various voluntary insurances including Life insurance, Disability Insurance, Accident Insurance, etc.

Minimum Qualifications: Associates degree with experience or equivalent 5 years of corporate quality leadership activities.

Interested candidates should respond to this post via email and provide a resume AND cover letter to HR Dept. at;

jobs@highpowervtls.com

Salary : $70,000 - $80,000

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