Laboratory Medical: Quality Control Technician II

Perform a wide variety of activities to support the Quality Management System. 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-checks 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.

Log returned instruments from the field. 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.

As necessary, process instrument documentation for return to repair facility, and pack instruments as required. Other duties as assigned by supervisor. Supervisory Responsibilities This job has no supervisory responsibilities.

Requirements: Ability to follow Good Manufacturing/Laboratory Practices (GMP and GLP). 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.

Bachelor's degree in a scientific or technical area or equivalent combination of experience and education. Preferred: At least one year in quality assurance role in medical device industry is preferred. As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Jeny Jones M: (248) 275-1984