Quality Analyst I - Evenings (2:30pm - 11:00pm) M-F

LSI Solutions Inc•Victor, NY
•$21 - $27•Onsite

About The Position

LSI Solutions is hiring a Quality Analyst for onsite work in Victor, New York. The posting describes Level I, II, and III responsibilities; the listed role is Quality Analyst I on the evening shift, Monday through Friday, from 2:30 p.m. to 11:00 p.m. The hourly pay range is $21.00–$27.00, plus a $2.00-per-hour shift differential. The Quality Analyst performs quality control inspection, in-process audits, and documentation review in a regulated medical-device manufacturing environment. Level I work includes accurate paperwork, cleanroom work, detailed record review, document retrieval, material transactions, inspection of product status, enforcement of documentation practices, and control of nonconforming product. The posting also outlines progressively advanced responsibilities for Levels II and III, including metrics, audits, continuous improvement, project support, nonconformance coordination, and assistance with training and supervision.

Requirements

  • Excellent verbal and written communication skills with colleagues and various levels of management.
  • Ability to follow written and verbal instructions and communicate effectively with cross-functional teams.
  • Ability to exercise independent judgment and work alongside team members.
  • Proficiency with Microsoft Office applications, including Excel.
  • Working knowledge of ERP systems and electronic databases.
  • Attention to detail, technical aptitude, and process-oriented troubleshooting skills.
  • Ability to maintain cooperative relationships that support teamwork.
  • Associate degree in a technical discipline preferred; a high school diploma or equivalent and two years of demonstrated success in a highly regulated manufacturing environment are acceptable in lieu of an associate degree.
  • For Level II, ability to create metrics, maintain databases, analyze and recognize trends and inconsistencies; experience with continuous improvement efforts; and familiarity assisting with quality audits.
  • For Level III, demonstrated ability to assist in supervising, training, and coaching others.

Nice To Haves

  • Quality Control Inspection, Line Audit, and Documentation Review experience.
  • Associate degree in a technical discipline.
  • ASQ CQPA or CQA certification.
  • Familiarity with GMPs, quality standards, and regulatory compliance.

Responsibilities

  • Process paperwork accurately and neatly.
  • Work in a cleanroom environment.
  • Maintain consistent quality and workmanship.
  • Conduct detailed records review and search for documents in Grand Avenue Software (GAS).
  • Perform all process steps within two product families.
  • Properly transact materials in the ERP system.
  • Conduct inspection and in-process audits of material status throughout product realization.
  • Enforce good documentation practices within Device History Records.
  • Originate nonconformance reports and segregate and control nonconforming product.
  • At Levels II and III, perform Level I functions independently; support cleanroom and quality-system processes; participate in metrics reporting, database maintenance, standard-work development, internal audits, continuous improvement, and Quality Engineer projects; perform preventive-maintenance activities such as bioburden and environmental monitoring; coordinate nonconformance reports; and assist with staff supervision, productivity monitoring, training, coaching, and team support.
  • Perform other duties as assigned.

Benefits

  • Bonus plan.
  • 401(k) plan with company match.
  • Tuition assistance.
  • Employee Assistance Program (EAP).
  • Product discounts.
  • 15 paid holidays, PTO, and sick time.
  • Medical, vision, and dental insurance effective the first day of employment.
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