Job Description

BOMImed Inc.,

a Winnipeg based, medical device manufacturer and distributor of airway management, anesthesia, critical care, warming therapy and diagnostic devices, is looking for a highly organized, motivated, thorough, Quality Assurance & Regulatory Associate to join our team.

The successful candidate will be responsible for supporting the organization's quality and regulatory compliance initiatives. This role involves maintaining and managing quality documentation, conducting internal audits, performing product inspections, and assisting the Lead with regulatory renewals and submissions. The associate will work closely with the Quality & Regulatory Lead to ensure adherence to industry standards, including ISO requirements, and will contribute to continuous improvement efforts within the Quality Management System.

Duties & Responsibilities:

Collaborate with the quality team to identify and develop documentation necessary to meet quality objectives.

Assist with managing the document control processes, including the creation, maintenance, and archiving of quality records.

Maintain and update quality system feedback documentation, including complaints, Corrective and Preventive Actions (CAPAs), and nonconformance reports.

Collect, compile, and analyze quality and regulatory data to support compliance and continuous improvement.

Identify, document, and communicate nonconformances to the relevant leaders.

Conduct internal audits and accurately document findings and corrective actions.

Perform product inspections, ensuring compliance with quality standards and specifications.

Assist with inventory control tasks, ensuring accurate record-keeping and compliance with quality protocols.

Support external audit preparation by gathering required documentation and assisting with audit processes.

Assist with the preparation and submission of regulatory renewals and applications.

Ensure ongoing compliance with applicable quality standards and industry regulations, including ISO requirements.

Execute procedures as outlined in the BOMImed Quality Management System.

Stay up to date with relevant regulatory changes and industry best practices.

Perform additional related duties as assigned.

Skills Required:

Exceptional written and verbal communication skills, with the ability to create clear and accurate documentation.

Strong analytical, critical thinking, and problem-solving abilities.

Proven ability to manage multiple tasks efficiently while maintaining a high level of accuracy and meeting deadlines.

Highly organized, with strong time management ability.

Detail-oriented.

Proficient in Microsoft Office applications, including Word, Excel, and Outlook, as well as internal computer systems.

Education and Experience Required:

High school diploma

Experience in Quality or Regulatory departments or related office experience is an asset.

Experience with document control and ERP systems is an asset.

Quality inspection and auditing experience is an asset

BOMImed offers a competitive salary, comprehensive benefit package and a positive work environment. If you believe this is an opportunity that is well matched to your skill set and capabilities, please apply!

BOMImed is an equal opportunity employer and welcomes applications from all qualified candidates. We thank all applicants for their interest, but only those selected for an interview will be contacted.

Job Types: Full-time, Permanent

Pay: $38,000.00-$40,000.00 per year

Additional pay:

Bonus pay
Benefits:

Casual dress Company events Company pension Dental care Disability insurance Employee assistance program Extended health care Life insurance On-site gym On-site parking Paid time off Vision care
Schedule:

Monday to Friday No weekends
Education:

Secondary School (required)
Experience:

office/administrative: 1 year (required)
Work Location: In person