Senior Quality Assurance Specialist
- Stouffville, ON
- Contract
- Full-time
- 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.
- 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