Job ID 20000A9M
Available Openings 1
PURPOSE AND SCOPE:
Under general supervision supports the organization by assisting with initial compliance and ongoing preparation, testing, and monitoring of conformance to established quality systems processes and standards for manufacturing and production.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Follows established company policies and procedures and applies acquired job skills to perform various quality systems tasks.
- Performs evaluation of internal controls, communications, risk assessments, and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
- Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them.
- Facilitates internal training on quality assurance requirements, processes, and procedures, as needed.
- May perform audits and risk assessments.
- Performs functions that require full knowledge of general aspects of the job.
- Works on assignments that are semi-routine in nature, but recognizes the need for occasional deviation from accepted practice.
- Contacts are typically with individuals within own department and occasionally with contacts outside own organization. Contacts involve obtaining or providing information or data requiring some explanation or interpretation.
- Escalates issues to supervisor for resolution, as deemed necessary.
- Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
- Assists 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.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Lifting document files up to 40 pounds may be required.
- Minimum travel may be required (less than 10%).
High School Diploma required; Associate's Degree preferred in a technical discipline.
EXPERIENCE AND REQUIRED SKILLS:
- Minimum 1 – 2 years of related quality systems experience, preferably within a regulated industry.
- Excellent written and verbal communication.
- Efficient data entry using computer keyboard.
- Knowledge and experience in SAP preferred.
- Ability to work with limited supervision, multi-task, and possesses attention to detail.
- Experience in FDA regulated environment, pertinent to GMPs and ISO 13485 preferred.
- Basic knowledge of 21 CFR Part 11 compliance is a plus.
- Knowledge of MS tools including MS Office Suite, Adobe, and PTC Windchill preferred.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
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