1st Shift Oper. Quality Tech
They are willing to look at someone very junior as long as they have clean room exp.
Responsibilities
Inspect and record results of work on Incoming raw material, In-process, or Lot Qualification at various stages of the production process, distribution process to determine and maintain the quality and reliability of our product.
Assess and complete inspection reports and records including the entry of data into various electronic systems. (For example – Word, Excel, SAP, Electronic DHR systems, Oracle Agile, and others).
Generate, review, and maintain quality records in support of the Quality System. (For example – device history records and training records)
Ensure the equipment calibration status is within the timeframe of use.
Assist the Quality Manager in notified body and regulatory authority audits and inspections.
Works from specifications, work plans, procedures, and general instructions from either Quality Engineers, Quality Supervisor, or the Quality Manager.
Required to maintain and enforce cGMPs.
Safely follow standard operating procedures including but not limited to quality standards, material handling, and record keeping. Must follow all Good Manufacturing Practices (GMPs), Good Documentation Practices (GDPs), and Good Laboratory Practices (GLPs).
Preferred Competencies:
Familiarity with measurement instrumentation such as micrometers, calipers, tensile testers, video microscopes, and optical gauging products preferred.
Experience working in a lab setting environment in the medical device industry.
The ability to use stereoscopes and varying microscope setups.
Vision capability to inspect small parts|components|labeling (Corrective lenses allowed)
Please send resumes to Monique at [email protected] or call/text at (978) 914-1790
Pay: $25.00 per hour
Location:
- Ayer, MA 01432 (Preferred)
Shift availability:
- Day Shift (Preferred)
Ability to Commute:
- Ayer, MA 01432 (Required)
Work Location: In person
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