Job Description
Job Description
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).
- Notifies Quality or Operations Leadership of any discrepancies to ensure quality standards and safety of operations are maintained at all times.
- Maintain a clean work environment suitable for medical device manufacturing and cleanroom production.
- Performs other duties as required
Required Skills and Competencies
- Excels at the organization and maintenance records accurately.
- Self-starter capable of dealing with a variety of tasks in a fast paced, multi-tasking environment.
- Must be proficient in English language to be able to read documentation, communicate, and write.
- Mathematics – Basic mathematics skills (adding, subtracting, multiplying, dividing)
- Autonomy - Capable of working independently with minimal instruction from their supervisor.
Education and Experience
Minimum Requirements:
- High School diploma
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.
Physical Requirements:
- Required to stand for up to 75% of working time per shift, with walking at least 50% of working time per shift.
- Required to reach above shoulder frequently and below waist occasionally.
- Required to push and pull.
- Ability to lift up to 20lbs occasionally, 5-20lbs frequently.
- Vision capability to inspect small parts/components/labeling (Corrective lenses allowed)