Job Title: Quality Management System (QMS) Analyst
Job ID #: 6089
Location: Canada, ON, Waterloo
Deadline: 05/09/2013
Functional Area: Research & Development
Department: Corporate
Job Type: Regular
Education Required: Bachelors/3 year Degree
Experience Required: 8 years +
Region: Americas
Position Description:
Bringing structure to the unstructured by unleashing the power of information
OpenText Enterprise Information Management (EIM) technologies and business solutions allow organizations to take full advantage of enterprise information to gain better business insight, capitalize on opportunities to positively impact the business, improve process velocity, reduce risks related to information governance, and protect sensitive information and intellectual property from internal leaks and external threats.
With growing volumes and a host of formats to manage and leverage, organizations need to bring structure to the unstructured.
By doing so, they will be unleashing the power of information to drive faster decision making, improved agility, strong security policies, and an increased ability to both exploit the opportunities and control the risks of enterprise information.
OpenText provides solutions across the entire range of core EIM capabilities – sophisticated, secure, high-value, and cost-effective – onsite, via mobile devices, private cloud, or in the cloud.
Overview:
As a Quality Analyst responsible for our quality management system, you will be responsible for the daily operations of our quality management activities. You will plan, coordinate, train, and execute internal audits of our processes. You will also coordinate and execute all aspects of our Customer audit program including the setup, actual audit, and follow-up activities. Corrective Actions to improve processes and address issues identified in our audits will also be an important role. You will also be responsible for Process Migration and overall maintenance of our quality management system, including SOPs.
What you will do:
Internal Audits
• Coordination, planning, and execution of our Internal Audit program
• Training new and existing auditors as needed
Customer Audits and Requests
• Work with Customers and other internal teams to complete Customer requested audits
• Setup Customer audits including needed resources
• Facilitate completion of the onsite audits
• Process and facilitate responses to Customer audit findings including creating Corrective Actions and facilitating completion
• Respond to Customer questions and surveys regarding development and quality management related items
Corrective and Preventative Actions (CAPA)
• Manage our CAPA system
• Create CAPAs for audit findings
• Facilitate completion of CAPAs in a timely manner
Process Migration
• Coordinate the integration of new teams into our standard processes when needed (acquisition, reorganization, etc.)
Quality Management System
• Manage our Quality Management System
• Maintain and update the PDS Dashboard
• Review, approve, and publish standard operating procedures
• Communication on quality management related activities
Position Requirements
• 8+ years of experience in quality management, preferably in software development
• Bachelor’s degree or equivalent
• Experience with Microsoft Office (Outlook, Word, Excel, PowerPoint)
• Understand the fundamentals of the World Wide Web and browser technology
• Experience working with customers in an audit environment, preferably with FDA regulated customers
• Knowledge of software development lifecycle methodologies.
• Strong organizational skills
• Strong analytical and problem solving skills
• Strong interpersonal skills and ability to deal effectively in a team environment
• Strong verbal and written communication skills
• Internal Audit experience with a focus on planning and training
How to Apply: Click here
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