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, R&D;/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. *LI-NZ1