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Job Details

Compliance Investigator - Complaints

Company name
ICU Medical, Inc

Location
Austin, TX, United States

Employment Type
Full-Time

Industry
Engineering, Sciences, Compliance, Manufacturing

Posted on
Jun 23, 2022

Valid Through
Oct 06, 2022

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Profile

Compliance Investigator - Complaints','22300872','!*!FLSA Status: Exempt 

Position Summary:

The Compliance Investigator coordinates complaint investigation activities and projects to ensure regulatory compliance, and develops, tracks, and manages customer complaint investigations per procedures.

Assures all investigation documentation adequately addresses root cause, corrective & preventive actions and product impact.

The investigator writes and presents Site Quality Review Team presentations, and writes Field Alert Reports for submission to the FDA.

Essential Duties & Responsibilities:

•Conduct investigations into process excursions, procedural exceptions and nonconforming events that contribute to the root cause of customer complaints. 

•Ensure root cause, corrective action preventative action (CAPA), and product impact are thoroughly addressed in investigations. Synthesize recommendations for action based on procedural requirements, decision flowcharts, and critical thinking.

•Document investigations results. 

•Develop, implement, manage and track effectiveness of corrective action plans for exceptions.

•Provide training and conduct verification assessments to ensure adequate maintenance of quality systems and processes as required.

•Manage projects to ensure they are completed within the required time schedule as required per quality systems.

•Provide support activity during regulatory or 3rd party audits.

•Prepare departmental metrics.

•Utilize trend data to develop schedule and incorporate into facility investigations.

•Ensure accurate project schedules are maintained and communicated to management.

•Write field alert report and prepare and deliver notifications to management. 

•Participate on committees/teams supporting GMP compliance programs.

•Adhere to all company guidelines, SOPs and ensure required compliance training is up to date.

•Monitor GMP and regulatory compliance activities critical in a regulatory inspection.  Communicate GMP violations and quality systems deficiencies to management and recommend MQ product release holds until the violation is addressed

•Perform other related duties as assigned or required.

Knowledge, Skills & Qualifications:

•Must have working knowledge of Good Manufacturing Practices and regulatory requirements.  

•Strong communication and organizational skills.  

•Ability to communicate with all levels of management. 

•Must possess strong technical writing skills to document investigation findings.

•Problem solving will be addressed in two specific ways:  People and Processes.  

    oIn the area of people, he/she must be able to foster a participative approach to problem solving. Must also be able to build an atmosphere of trust, open communication, and respect in order to handle the difficult issues in investigations and corrective action follow up.  

    oIn the area of processes, he/she will be required to utilize technical expertise to identify and understand problems that may elevate to serious compliance issues.

Education and Experience: 

•Must be at least 18 years of age

•Bachelor’s Degree is required: Engineering, Science, or Manufacturing (other 4yr degrees considered with commensurate experience)

•CQA or CQE preferred

•Minimum of 2 years’ experience in Quality, Manufacturing, Engineering, or R&D functions or any combination of the above.  

•Preferred experience in one or more of the following areas:  Validation principles; Pharmaceutical manufacturing methods; Documentation systems, Quality Systems; analytical or microbiological testing principles.  

•Experience in project management and quality engineering principles preferred.  

Physical Requirements and Work Environment: 

•General office conditions with occasional entry to laboratories, warehouse, manufacturing, and clean-room manufacturing spaces.  

•Handle returned IV bags that may or may not have been used on customers, or might contain hazardous substances. (i.e. cancer drugs).  

•Occasional lifting of sample boxes is required. Must be able to lift up to 25 lbs. unassisted.

•Typically requires travel less than 5% of the time

ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

','','US-TX-Austin','','Full-time','Day Job','','Compliance Investigator - Complaints

Company info

ICU Medical, Inc
Website : http://www.icumed.com

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