• 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
• May support returned instrument processing
  o Log returned instruments from the field.
  o Decontaminate returned instruments in a Biohazard level II environment following standard operating procedure and documenting decontamination as required.
  o Inspect returned instruments for damage, and performing basic investigation and documenting results prior to second level processing.
  o As necessary, process instrument documentation for return to repair facility, and pack instruments as required.

Qualifications

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• The requirements listed below are representative of the knowledge, skill, and/or ability required.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Ability to follow Good Manufacturing/Laboratory Practices (GMP and GLP)

Education and/or Experience

• 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.

Language Skills

• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to write routine reports and correspondence.
• Ability to speak effectively before small groups of customers or employees of organization.

Mathematical Skills

• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Computer Skills

• To perform this job successfully, an individual should have knowledge of Database software; Internet software; Inventory software; Spreadsheet software and Word Processing software.