Sr. Quality Systems Technician

PURPOSE AND SCOPE: Conducts Quality audits of products assuring compliance with company standards are maintained and product integrity is preserved. Consults with management to resolve quality, production, and efficiency problems.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Under general supervision, follows established company policies and procedures and applies acquired job skills to fulfill duties in accordance with requirements of the QSR regulations, the ISO-9001 standard, Corporate and on-site policies and procedures.
• Participates in quality audits to ensure compliance with regulations and internal policies and procedures.
• Ensures records/activities are properly documented in accordance with regulations.
• Works on assignments that are moderately difficult, requiring judgment in resolving issues and/or in making recommendations.
• Follows all policies, guidelines, and Standard Operating Procedures (SOP’s) as required.
• Performs functions that require full knowledge of general aspects of the job.
• Maintain a teamwork approach to all tasks and works effectively with other departments.
• Normally receives no instruction on routine daily work, and general instructions on newly introduced assignments.
• May provide assistance to lower-level staff with more complex support tasks that require a higher level of understanding of functions, as directed by immediate supervisor.
• 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.
• Assist with various projects as assigned by direct supervisor.
• Other duties as assigned.

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.
• The position involves moderately active work involving walking and/or standing for considerable lengths of time. Bending to floor level is required and the employee must be able to routinely lift objects weighing up to 50 lbs as high as 5 ft above floor level.

EDUCATION:

• High School Diploma required.
• Associate’s Degree Preferred.

EXPERIENCE AND REQUIRED SKILLS:

• Minimum 2 – 4 years of related experience.
• General knowledge of GMP regulations,
• Must have good organizational skills and be able to perform work with little supervision.
• Well established computer skills with database, spreadsheet, and word processing programs.
• Strong oral and written communication skills.
• Strong attention to detail.
• Mathematical aptitude is required with a good background in algebraic skills and measurement skills.

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Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws. Fresenius Medical Care is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sexual orientation, gender identity, parental status, national origin, age, disability, military service, or other non-merit-based factors