SourceVolt Services Group
- Conduct product testing, including testing to support complaint investigations and stability verification
- Generate product testing results reports
- Review production batch records (DHR's) for accuracy and completeness in order to approve intermediate products for use in production. Review finished goods batch records. Report all deviations in these records and assures these have been addressed and resolved prior to issuing approval.
- Conduct spot-check inspections/audits of production operations
- Participate in the internal audit program
- Write, review and approve Standard Operating Procedures (SOPs) as necessary
- May assist in supporting the Document Control program, record retention areas, and sample retention areas
- Decontaminate returned instruments in a Biohazard level II environment following standard operating procedure and documenting decontamination as required.
- Inspect returned instruments for damage and performing basic investigation and documenting results prior to second level processing.
- Process instrument documentation for return to repair facility.
- Bachelor's degree in a scientific or technical area or equivalent combination of experience and education.
- At least one year in quality assurance role in medical device industry is preferred.
- Ability to follow Good Manufacturing/Laboratory Practices (GMP and GLP)
- Ability to follow standard operating procedures and accurately document results
- Understanding the manufacturing processes of Company products and ability to recognize deviations from approved documented procedures
Quality Assurance Product Support Specialist - $3k Sign-On Bonus
Tire Technician - Training Provided - Scarborough, ME