PTS Diagnostics is looking to solve issues related to product performance surveillance and complaint investigations by ensuring thorough investigation, accurate reporting, and upholding quality and customer safety.
Requirements
- Knowledge of good laboratory practice in a regulated industry is required
- Working knowledge of applicable FDA and ISO regulations
- Working knowledge of Quality System Regulations
- Familiar with statistical techniques
Responsibilities
- Process and perform analysis of PTS test strips using whole blood and control materials.
- Conducts investigations and/or experiments to test system performance which may include chemistry, architecture, and/or analyzer issues relating to all complaints.
- Captures and records test data utilizing PTS procedures.
- Prepares blood samples for analysis following established protocols.
- Performs testing using reference analyzers and/or OEM systems.
- Data entry and analysis
- Generates reports and/or charts using Microsoft Excel and/or Microsoft Word.
Other
- Detail oriented
- Possess strong verbal and written communication skills
- Able to interpret and follow written and verbal instructions
- Adept at interfacing with various disciplines in an organization
- Five (5) years related experience and/or training in the Medical device or related industry.
