Job Information
Fresenius Medical Care North America Supplier Quality Engineer I in Ogden, Utah
PURPOSE AND SCOPE:
Responsible for supplier quality relations at Fresenius Medical Care. Develops and maintains strong relationships with suppliers through open channels of communications.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Drives supplier process improvements. Develops supplier quality systems and ensure continuous improvement of products and processes.
Conducts supplier audits, issues associated audit reports, and follows up.
Works with supplier QFN’s, NCR’s and CAPA.
Ensures specifications and other technical information/assistance is available to the supplier to enable the supplier to provide products of high quality.
Composes inspection records, specifications and other reports and communications.
Assures data accuracy and integrity of reports and documents.
Evaluate supplier performance through appraisal of the product, supplier audits and supplier-rating programs to identify modes of corrective and preventive action. Develop and coordinate supplier partnership programs and certification programs.
Utilizes "quality tools" such as Pareto charts, flow charts, control charts, scatter diagrams and histograms to analyze data.
Maintains general housekeeping of working area and plant.
May provide assistance to junior level staff with general tasks that require a better understanding of functions, as directed by immediate supervisor.
May refer to senior level staff for assistance with higher level problems that may arise.
Escalates issues to supervisor/manager for resolution, as deemed necessary.
Review and comply 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.
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.
Regularly required to talk or hear.
Frequently required to stand; walk and sit.
Occasionally required to use hands to finger, handle, or feel; reach with hands and arms; stoop, kneel, crouch, or crawl and require personal protective equipment required may include: safety shoes, safety glasses, hearing protection, Clean Room suit, respirator, back or wrist brace, smock, hair net, shoe booties, face mask.
Ability to lift and/or move up to 25 lbs.
Occasionally exposed to moving mechanical parts and risk of electrical shock.
The noise level in the work environment is usually moderate.
Travel to supplier sites may be required.
EDUCATION:
Bachelor’s Degree required
EXPERIENCE AND REQUIRED SKILLS:
2 – 5 years’ related experience; or an advanced degree without experience; or equivalent directly related work experience.
CQE Certification preferred.
Experience in industry, medical device or drug-related manufacturing experience is preferred.
Familiarity with quality records and be able to write inspection records.
Familiarity with techniques for assuring data accuracy and integrity, and be able to conduct problem identification analysis and corrective action investigations.
Experience with computer data processing and other software used to analyze and report scientific and engineering activities is essential.
Strong oral and written communication skills.
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.