Quality Assurance Associate

3 months ago

Ottawa, Canada Spiderwort Inc. Full time

Spiderwort is building the framework for the future of regenerative medicine through the development of innovative plant-based biomaterials that promote the repair and regeneration of living tissues, including the spinal cord.

Spiderwort is looking for a talented Quality Assurance Associate to join its organization, responsible for ensuring a high level of compliance with ISO 13485, 21 CFR 820 and Health Canada Medical Device Requirements as well as company procedures. The role will provide support for all quality/compliance related matters and will partner with the Research and Development team to design and develop medical devices.

Reporting to the Quality Assurance Manager, the Quality Assurance Associate supports QA activities, provides training, and performs internal audits. This position determines final disposition of materials, i.e. releasing or rejecting, and must ensure that all regulations and procedures are upheld.

**Responsibilities**:

- Conducts incoming inspection, batch record review and product disposition, e.g., release, reject, or product hold for further clarification or investigation
- Provides oversight to various quality systems through which quality history and trending are monitored and corrective/preventative actions or quality improvements are recommended, implemented and consistently managed
- Ensures effectiveness using thorough investigation, root cause analysis, and CAPA when deviations, non-conformances or complaints are raised
- Assists with complaint and potential adverse event investigations; reporting in a timely manner as detailed in applicable SOPs and regulations
- Participates in internal audit program as required
- Participates in inter-departmental meetings and teams to represent the quality department interests and subsequently serve as a communication conduit to collect/distribute related information
- Participates in the validation and qualification process for new products, equipment, processes, etc.
- Follows GMP and regulatory requirements while ensuring quality standards are met
- Observes and supports all safety guidelines and regulations
- Demonstrates the company mission, vision and values statements, policies, and current SOPs
- Performs other related duties as required

**Requirements**:

- Degree in a related science (e.g. Chemistry, Microbiology)
- Minimum 2 years of practical experience in a Quality function, or equivalent experience in a leadership role within Operations
- Practical experience obtained as part of a higher degree (e.g. Ph.D.) will be considered equivalent experience if the higher degree is in a related science
- Experience in a medical device (or pharmaceutical) manufacturing environment would be an asset (cGMP)
- Ability to work independently with mínimal supervision
- Excellent verbal and written communication skills
- Strong problem solving and decision-making skills
- Decisiveness and attention to detail

**Job Types**: Full-time, Permanent

**Salary**: $45,000.00-$60,000.00 per year

**Benefits**:

- Casual dress
- Company events
- Dental care
- Disability insurance
- Discounted or free food
- Extended health care
- Life insurance
- Paid time off
- Stock options

Flexible Language Requirement:

- French not required

Schedule:

- 8 hour shift
- Day shift
- Monday to Friday
- No weekends

Application question(s):

- Do you have eligibility to work in Canada?
- Are you able to work onsite in Ottawa Monday to Friday?

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- Quality assurance: 2 years (required)
- Medical terminology: 1 year (preferred)

Work Location: In person

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