Baylis Medical is a leading developer, manufacturer and supplier of high-technology medical devices for cardiology, radiology and spine products. Baylis Medical products are marketed in over 65 countries. Our goal is to conceive, develop, manufacture, and sell state-of-the-art medical products that will improve the lives of people around the world. To assist us in realizing our goal, Baylis Medical adheres to four main guiding principles: Technological Leadership, Employee Development, Customer Service and Corporate Social Responsibility.
The Technical Writer is fully trained and capable of carrying out complex technical writing activities within area(s) of training and specialization. The Senior Technical Writer will collaborate with key stakeholders within the company and drive the full scope of technical writing deliverables.
Snapshot of Responsibilities
- Create and/or revise SOP's, templates, labeling, reports and quality documentation as required by ISO13485, FDA, EU and other regulatory bodies according to the Baylis Quality Management System
- Determine and negotiate on the scope of technical writing within projects and is responsible for conducting independent work planning and execution to meet project deadlines
- Gather technical information from customers, subject matter experts and existing technical documents, reports, references and manuals to create content to support compliance
- Demonstrate a thorough understanding of company product lines, document structure and customer needs (internal and external)
- Implement documentation to our EQMs and support regulatory submissions
- Lead and participate in internal and external quality audits.
- Provide technical and project level leadership to junior technical writers.
What you bring to the team
- A technical degree and/or technical writing certification with 4-5 years' experience OR an equivalent of education and experience
- Internal auditing experience is an asset
- Experience in design control processes as required by ISO13485, FDA, EU and other regulatory bodies
- Knowledgeable in software such as, Microsoft Office suite, Adobe Illustrator, Solidworks, and electronic QMS software (ex. ETQ)
- ERP (ex. SAP/EPICOR) experience is an asset
- Willingness to take on new challenges and solve problems with minimal direction
What we have to offer
- Opportunity for growth
- Competitive salary and benefits
- RRSP matching
- Flexible start times
- On site gym facility
Baylis Medical is an equal opportunity employer and encourages applications from all qualified individuals. Please inform us if you require any accommodations during the recruitment process.
While we thank all applicants, only those being considered for an interview will be contacted.
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