Quality Specialist

Summary: Seeking a Quality Specialist to manage calibration systems, document changes, and perform batch record reviews in compliance with ISO 13485 and CFR 820 standards.

• Requirements:

  • High School Diploma or GED
  • Ability to read and comprehend work instructions
  • Basic computer skills for data input
  • Competency with Microsoft Office programs
  • Familiarity with ISO 13485 standard and CFR 820 regulations
  • Understanding of Statistical Process Control principles
  • Proficiency with dimensional gages (caliper, micrometer, drop indicator, comparator)

• Responsibilities:

  • Coordinate document change activities for control plans, procedures, work instructions, and forms
  • Manage the calibration system, ensuring equipment is calibrated and stored properly
  • Participate in the Internal Auditing program as primary auditor and trainer/facilitator
  • Monitor quality system activities to ensure timely audits and address corrective actions
  • Perform batch record reviews for accuracy before shipment to customers

Pay Details: $20.00 to $24.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.