Senior Quality Assurance Specialist

Cook Group

  • Stouffville, ON
  • Contrat
  • Temps-plein
  • Il y a 12 jours
Overview:The primary function of the Senior Quality Assurance Specialist is to ensure that entities are always inspection ready while being a champion in supporting the quality culture within the organization. The primary function will be to maintain the entity's quality management system while investigating and resolving quality related issues.Responsibilities:
  • Responsibilities
  • Author and perform investigations related to Quality Issues including nonconformances/deviations (including proper root cause analysis, rework inspections where applicable).
  • Coordinate /investigate / own CAPAs / SCARs within various electronic systems.
  • Lead change management activities (which may include attending Quality Review Board Meetings, and reviewing changes for impact to established QMS).
  • Lead the execution of both process and document control.
  • Perform Risk Assessment and FMEA Activities.
  • Support hiring process as required and act as mentor for new hires
  • Author documentation e.g. procedures, policies, instructions, training, and nonconformances.
  • Own Quality Management Review data collection and analysis (including: preparation of Key Process Attachments, meetings minutes and action items.
  • Prepare quality related reports as required by the organization.
  • Conduct, schedule and support both Internal and External Audits as required.
  • Lead relevant Continuous Improvement activities.
  • Author and perform trending of quality data, ensuring proper application of CAPA and feedback loops are effective.
  • Perform gap analysis (documentation/against relevant standards)
  • Other duties as assigned by management.
Qualifications:
  • Bachelor's degree in related field, or experience of such kind and amount to provide a comparable background; preferred 5 years related experience.
  • Knowledge of medical device regulations, including pertinent standards is preferred
  • Proficiency in Microsoft Office Software (Word, Excel, PowerPoint, and Outlook)
  • Must have effective communication skills with proven ability to work in collaborative and independent work situations and environments with minimal supervision
  • Proven ability to lead both local and global projects.
  • Ability to remain calm and receptive in fast-paced situations.
  • Ability to adhere to safety requirements
  • Ability to comply with the Cook Code of Conduct, Company Values, Competencies, and Company Compliance requirements
  • Physical Requirements
  • Works under general office environmental conditions
  • Sitting for extended periods utilizing close visual acuity for working with computers, etc.
  • Must be able to perform the essential functions of the job. (Subject to reasonable accommodation requirements under the ADA-AMER)
  • Ability to travel between Cook facilities as required
  • Regional Requirement
  • Understand ISO 13485 and other regulatory requirements within a distribution and import environment
  • Coordinate/Conduct//Lead training of staff to QMS
  • Support Regulatory Affairs in working with government authorities in regard to quality issues as needed
  • Prepare and Execute Quality Plans
  • Ability to meet required deadlines for projects/tasks
  • Perform gap analysis (documentation/against relevant standards
  • Understand and be able to apply principles of good practices pertaining to warehousing and distribution
  • Perform Quality reviews on product holds/releases within the required system

Cook Group