What are the responsibilities and job description for the Quality Systems Technician position at HeartCentrix?
PURPOSE AND SCOPE:
Conducts Quality audits of products assuring company standards are maintained and product integrity is preserved. Consults with
management to resolve quality, production, and efficiency problems. Functions as an information source to employees when quality
issues occur.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Under close supervision, acquires job skills and learns company policies and procedures to complete routine tasks. Fulfill
duties in accordance with requirements of the QSR regulations, the ISO-9001 standard, Corporate and on-site policies and
procedures.
Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends including
failed processes, stability studies, recalls, corrective actions, and re-validations.
Develop plans by conducting analyses; identifying critical control points and preventive measures; establishing critical
limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.
Works on assignments that are routine in nature, determine whether or not communications regarding company equipment
are complaints and whether or not complaints might be reportable to the FDA.
Analyze equipment complaints to determine the probability that the reported problem is resolved and, if not, whether additional
action to resolve the problem needs to be taken.
Document investigation steps and results.
Communicate with company personnel to investigate complaints.
Follow all policies, guidelines, and Standard Operating Procedures (SOP’s) as required.
May refer to senior staff for assistance with day-to-day problems that may arise.
Escalates issues to supervisor for resolution, as deemed necessary.
Assist with various projects as assigned by direct supervisor.
Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable
addendum for department or location specific functions.
EDUCATION:
High School Diploma required
EXPERIENCE AND REQUIRED SKILLS:
0 – 1 year’s related experience.
Understands fundamental concepts of at least one company product line.
Understands basics concepts and principles of dialysis.
Basic computer skills with database, spreadsheet, and work-processing programs.
Strong oral and written communication skills.
Strong attention to detail.
Salary : $19
