Senior Manager Quality Systems Integration Job Listing at Fresenius Medical Care in Ogden, UT

Healthcare

PURPOSE AND SCOPE:
The QS Integration Manager is responsible for ensuring oversight of the corporate-wide, centralized, integrated Quality Systems. This position is responsible for assisting the implementation, compliance, and maintenance of centralized quality systems operations, implementing and leading continuous improvement programs for the processes and products, interfacing with Manufacturing Operations, Product Development, and Supply Chain to ensure product conformance to specifications, and continuous improvements and ultimately continuous regulatory adherence.

CUSTOMER SERVICE:

• Responsible for driving the FMCNA culture through values and customer service standards.


• Accountable for outstanding customer service to all external and internal customers.


• Develops and maintains effective relationships through effective and timely communication.


• Takes initiative and action to respond, resolve and follow up regarding customer service issues with all customers in a timely manner.

PRINCIPAL RESPONSIBILITIES AND DUTIES:

1. Corporate QS Program expert located at the manufacturing facility.

2. Work closely with Quality, Manufacturing, RD/Engineering functions to ensure QS programs are effective to current requirements.

3. Responsible to ensure appropriate integration of all corporate-wide quality systems at the local facility.

4. Establish Quality System integration plans.

5. Educating / training on Corporate Quality System programs

6. Verifying adequate integration and application of the Corporate Quality Systems

7. Conduct Quality System audits for effectiveness.

8. Reporting status of the integration and application of the Corporate Quality Systems.

9. Understanding QSR, ISO and other applicable quality standards and regulations.

10. Other duties as assigned.

EDUCATION
B.S., M.S. or equivalent combination of certifications and schooling/training/knowledge accumulation in engineering and/ or life sciences.

EXPERIENCE AND REQUIRED SKILLS

• Detailed knowledge and understanding of current 21CFR 210/211, 312, 820, 806, FDA drug distribution regulations, ISO 13485, 93/42 EEC (Medical Device Directive), and the Canadian Medical Device Regulation, Canadian Drug Regulations, Mexican Device and Drug Regulations;


• 7-10 years of QS experience in a regulated industry; CQE a plus.


• Good knowledge of problem solving methods and tools; intermediate understanding of statistics.


• Knowledge of GCP practices and guidelines


• Familiarity with sources of key regulatory information;


• Excellent verbal and written communication and presentation skills, including effectiveness in conducting or participating in meetings, speaking before audiences, or providing training;


• Intermediate or better understanding/usage of M.S. Word, Powerpoint, Excel, Access, Project, and at least one flowcharting program (e.g., Visio);


• Strong interpersonal skills, especially in dealing with persons less familiar with quality philosophies, standards, and regulations;


• Computer skills: Microsoft Office Suite (including PowerPoint, Office, Outlook, Visio, Excel, Project) Share Point, Windchill, etc.

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