The External Manufacturing Quality Assurance (EMQA) Specialist will capture and trend Quality Data (Nonconformance’s, Deviations, SCARS, Change Controls, CAPAs) from multiple Quality Management Systems and will analyze quality data by using quality sciences, statistics and six sigma principles in order to identify quality improvement opportunities in the areas of Supplier Quality Management and Product Quality. These analysis will be presented at various governance boards, Quality Performance Indices and Management Review.
The EMQA Specialist will work directly with Valeant’s Finished Good (FG)/External Manufacturing (EM) suppliers, as well as Supplier Quality Engineers, Product Quality Engineers, Design Quality, Complaint Specialists, and Technical Support groups.
Work with Supplier Quality Engineers and Product Quality Engineers to implement effective quality improvements to support on-going manufacturing of products to meet or exceed internal and external requirements as well as to lower the Cost of Quality.
Extract Quality Data from multiple Quality Management Systems and statistically analyze in order to identify adverse trends utilizing six sigma principles.
Report results of Quality data analysis in the Global Quality Performance Index, EM Supplier Quality Management Council, Product Quality Reviews and Management Review.
Propose Quality Improvement opportunities to any adverse trends and work with Quality Engineers on verification of effectiveness of improvements.
Complete data analysis, Quality Performance Index reporting, Non-conformances and CAPAs within required timelines.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues with FG/EM suppliers, supplier quality engineers and quality engineers.
Participate in product design changes, and preventive actions as well as effectiveness verification activities, as required.
Directly support management team for activities related to Management Review, Critical Action Committee, EMQA Global Quality Performance Index and EM Supplier Quality Management Council.
The scope of this position is directly related to the North America EMQA Supplier Quality Organization.
The position will include routine interaction and communication with internal business stakeholders (Quality, Compliance, Supply Chain, R&D, Regulatory and Commercial) and external business partners (External Manufacturing groups).
Bachelor of Science degree in a scientific / engineering discipline (Pharmaceutical Quality, Mechanical, Biomedics, materials, Industrial, etc) or related technical field (microbiology, chemistry, etc) is required.
ASQ Certification preferred but not required (such as CQA, CQE, CMQ/QE)
Six Sigma Black Belt preferred but not required
Excellent communication skills (verbal and written).
Ability to successfully influence others within project teams regarding quality concerns.
Excellent organization and presentation skills.
10 years quality experience within the Pharmaceutical and/or Medical Device industry that included Quality Data Mining, trending and analysis utilizing statistical techniques.
Experienced in utilizing electronic Quality Management Systems and data bases such as Trackwise, CatsWeb, Master Control, Kintana, EBR
Experienced in Excel formulas and Macros, Access Data Base and statistical software (Minitab).
Demonstrated expertise in Implementing and maintaining quality systems
Ability to travel to internal and supplier sites as needed.
Proven track record of successfully working with cross functional teams in a fast paced and dynamic environment.
Familiar with 21 CFR Part 210, 211, 820, ISO 13485, ISO 14971, Council Directive 93/42/EEC (Medical Devices Directive) and Canadian Medical Devices Regulations.
Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes) and ability to mentor stakeholders in analysis of process data and metrics to identify root cause of complex problems and development and implementation of preventative or corrective actions.
Expertise in providing creative solutions to complex issues.
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