Quality Assurance

1 week ago

Winnipeg, Canada BOMImed Inc Full time

**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.

**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.
- 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.

**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

**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**:

- Quality and/or regulatory: 1 year (preferred)

Work Location: In person

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