Quality Assurance

7 days ago

Burlington, Canada WS Audiology EMEA, LATAM & Canada Full time

At WSAudiology, we pride ourselves on being the pioneers of innovative solutions within the hearing care industry, who have a shared passion for positive impact on our client’s hearing journey, and always go above and beyond as a team_

Join our Quality Assurance team Now hiring a Quality Assurance & Regulatory Affairs Specialist for our Burlington, Ontario location.

**What it’s all about**:
As a Quality Assurance & Regulatory Affairs Specialist, you are responsible for maintaining the local Quality Management System. This includes maintenance of local documents, implementation of the training concept, local implementation of the global CAPA/improvement system, internal quality reviews, data analysis and audit management. This role is for someone looking to wear multiple hats and wants a challenge every day. This is a **hybrid role**, and you will be required in the office approximately 3 days per week.

**What we offer you**:

- Competitive compensation package
- Comprehensive, employer-funded benefits package starting Day 1
- RRSP program with employer match starting Day 1
- Paid vacation, personal/sick days and Diversity Days (for December shutdown period)
- Education assistance program
- Mentorship and development opportunities

**What you will do**:

- Research and compile documentation for regulatory affairs and submissions to audits
- Maintain local QMS documentation to fulfil local requirements in addition to the global QMS
- Review, organize, implement, maintain and support local QMS, acting as a Quality Manager and Internal Auditor for ISO 13485
- Implement and maintain global training concept on local level including monitoring of training status
- Ensure company remains fully compliant with ISO standards
- Track trends of product/service quality-related KPIs
- Track, compile and report on Customer Complaints including investigation, follow up and closure of complaints (locally and globally)
- Develop quality metrics and provide analysis to senior management to support continuous improvement and optimization of quality in product and services
- Ensure the local implementation of global Corrective and Preventative Actions (CAPA) process to support continuous improvement both internally and externally, with suppliers, sub-contractors and vendors
- Host and lead meetings including senior management (locally and globally)
- Collect data and prepare and moderate local Management Review
- Prepare and participate during internal/external audits conducted locally
- Other related duties as assigned
- Review data and analyze reports; provide daily, weekly and monthly reporting to management team

**What we are looking for**:

- Degree in Science, Engineering, Business Administration, Quality Assurance or other related fields
- 5-8 years of experience with QMS and in an intermediate to senior Quality Assurance role
- Experience working in a Medical Device Manufacturing a strong asset
- Expert knowledge of Health Canada F&DA, MDSAP, ISO 13485
- Knowledge of US FDA CFR considered a strong asset
- Expert knowledge of leading internal ISO audits
- Excellent oral and written presentation and communication skills - you will be leading many meetings locally and globally on a daily, weekly and monthly basis
- Experience in local and global project management
- Can work independently and with a large team at a local level and a global level, supporting several countries in North America and globally
- Bilingual in English and French considered a strong asset

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