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101634_CAN - Analyst, Prin Quality-Contract Job

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Date: May 22, 2019

Location: Mississauga, ON, CA

Company: Boston Scientific

Location: [[Mississauga]], [[Ontario]], [[Canada]]
Additional Locations: [[Toronto]]
Hiring Manager: [[John Zagala]]
Recruiter: [[Linda Stansfield]]

 

 

Boston Scientific Ltd. is required to and will comply with certain provisions contained in the Accessibility for Ontarians with Disabilities Act, 2005 (AODA) and Part III-Employment Standards of the Integrated Accessibility Standards Regulation made under the AODA.

This 12 month contract position will provide support to the assigned quality system element in processing and analysis of Quality Processes and Sub-Process duties. This includes the collection, trending, and analysis of data for assigned quality system process and associated sub-processes. This resource will serve as a Quality specialist by assisting and leading the execution and tracking of assigned deliverables. In addition, this resource will drive in conjunction with their peers and project managers, the execution of projects designed to improve the compliance, efficiency, and effectiveness of the BSC Quality System and specifically the Quality System Process or Sub-Process for which they are assigned.

Requirements

  • Minimum 3-5 years’ RA/QA experience working in med device and/or pharma industry
  • Minimum BSc degree or equivalent
  • Knowledge of ISO 13485:2016 and Canadian Medical Device Regulations

 

Responsibilites

 

  • In the area of management review this resource to will assist senior leaders in making critical assessment of the health of the quality system by executing the required elements: including data collection, data base population and updating, logging and tracking of issues/action items, conducting analysis, generating reports, creating presentations, core team meetings, and meeting minutes.
  • Create summary presentations of the quality system process analysis for review by a variety of key stakeholders.
  • Work with QA and other leaders to identify areas within the quality system in need of improvement and manage Corrective and Preventive Actions or process improvement projects as appropriate. Support third party and internal audit preparation and execution. Be a Subject Matter Expert of supported areas of the BSC Quality System during internal and external audits.
  • Identifies and drives Continuous Improvement activities to reduce the burden on the BSC Network resulting from certain Quality System Processes and Sub-Processes.
  • Lead and facilitate elements of Quality System Integration activities, including but not limited to best practice analysis, benchmarking, harmonization and overall efficiency analysis.
  • Drive cross-functional solutions and provide input to Global Systems and Business Processes to ensure BSC Network is as efficient as possible as it pertains to the BSC Quality System processes and sub-processes.

Management Requirements

  • Not applicable

Job Scope and Leveling Guidelines

  • Knowledge: A seasoned, experienced professional with wide-ranging experience and expertise in a specialized field. Applies comprehensive knowledge of a particular field to resolve complex issues in creative ways. Full knowledge of other related disciplines. Uses in-depth knowledge of business unit functions and cross group dependencies/relationships. Is recognized as an expert in the work group.
  • Problem Solving: Develops solutions to diverse business problems of high complexity which require the regular use of ingenuity and creativity. Analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has specialized knowledge of various alternatives and their impact on the business. Challenges are frequently unique and solutions may serve as precedent for future decisions.
  • Planning and Organization: Plans and organizes project assignments of substantial variety and complexity. Initiates or maintains schedule for projects and project milestones.
  • Discretion/Lattitude; Supervision Received; Decision Making: Works without appreciable direction. Works independently on highly specialized projects with long range objectives.  Exercises considerable latitude in determining objectives of assignment. Selects methods and techniques to lead a project to completion. Develops departmental policies and procedures, new techniques and standards. Work is reviewed from a relatively long- term perspective, for desired results.
  • Business Relationships and Project Management: Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units. May lead specialized project teams which have a broad impact on the company utilizing cross-functional resources.  Provides leadership to business units.
  • Impact: Guides the successful completion of major programs and often functions in a project leadership role. Effects of decisions are long-lasting and influence the future course of the organization. Errors in judgement or failure to achieve results would result in the expenditure of large amounts of company resources.
  • Liason: Serves as a consultant to management and special external spokesperson for the organization on major matters pertaining to its policies, projects, or objectives. Uses diplomacy and tact to diffuse high tension situations, particularly with senior level internal and external contacts. Occasionally escalates the most serious issues to manager.
  • Mentoring: Participates in the development of others by facilitating training and providing feedback and guidance.

 

 

 

 

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Requisition ID: 447795

 


Job Segment: Medical, Medical Technology, Medical Device, QA, Healthcare, Quality