Quality Assurance Specialist

2 weeks ago

Vancouver, Canada Response Biomedical Full time

**Who we are**:
Response Biomedical Corp. has been transforming acute care diagnostic testing, with the central focus on improving patient outcomes and healthcare reform for over 20 years. Response Biomedical fosters a values-based culture, committed to making diversity and inclusion our way of doing business. We believe the people we work with including our partners, medical teams, and employees are the cornerstone of our success.

**What we do**:
Our RAMP platform is a global leader in diagnostic testing solutions for use in cardiovascular, infectious disease, sepsis, women’s health, arbovirus, and biodefense. We understand the stresses associated with rapid, accurate diagnosis when every minute counts, and are committed to collaborating with the teams that are dedicated to saving lives. We do this by providing lab-quality results within minutes that medical teams can trust, while reducing total cost of care.

**Who we are looking for?**

We are seeking for a seasoned Quality Assurance Specialist who is dynamic, self-motivated and solutions-focused to join our Quality Assurance team.

The Quality Assurance Specialist is responsible for ensuring that quality standards are met for the product and processes at Response. by providing ongoing customer satisfaction and ensuring that the company supports the core purpose of improving patient outcomes and saving lives globally.

**Key Responsibilities**:

- Quality Assurance_
- Maintains the effectiveness of the Quality Management System (QMS) and ensures adherence with applicable international standards and regulations related to Medical Devices (i.e., ISO 13485:2016, MDSAP and IVDR).
- Leads Quality Initiatives and Objectives to drive quality system improvements and ensures alignment with Corporate Goals.
- Identifies nonconformances, gaps, and/or inefficiencies in the system procedures or processes and initiates the appropriate corrective or preventive actions.
- Helps manage the change control and training processes with the QA Document and Records Control Specialist to ensure compliance with standards and regulatory requirements.
- Reviews and approves the following in the QMS database - document change requests, document revisions, Document Change Orders (DCO), Significant Change Notifications (SCN), and validation/verification/stability documentations.
- Provides guidance and trainings to the company related to QMS processes and procedures.
- Support the CAPA management process by ensuring that CAPA investigations/implementations are performed compliantly and closed in a timely manner.
- Support the evaluation of product safety and efficacy through risk-based approach by reviewing risk management documentation to mitigate risks.
- Support Supplier Management process by initiating SCARs to resolve vendor and material issues, if necessary.
- Prepares and participates in quality and regulatory audits, assuring readiness
- Participates in Management Review meetings, and projects to provide inputs, expertise and support needed.
- Quality Operations_
- Responsible for ensuring timely completion of nonconformances (NCs), variances (VRs), reworks (RWs), risk assessments and root cause analyses related to operations.
- Initiates NCs when deviations in the materials, inspections, documentation, or procedures is found. Collaborate with Operations to investigate the NC for root causes and for the appropriate correction, corrective, or preventive actions to apply.
- Supports ongoing flow of operations through process improvements and continuous support. Identifies gaps in the QMS, develops and drives cross-function implementation of corrections and improvements.
- Ensures the accurate status labeling and disposition of incoming materials, in-process materials, and products throughout the operations area.
- Participates and supports in training Operations staff on QMS requirements.
- Ensures the issuance of QMS documentation and manage the flow of records through to completion when required.

**Education, Work Experience, Knowledge, and Skills**:

- Formal Education_
- Post Secondary Degree preferably a Bachelor of Sciences or related areas
- Experience in health care, medical device, or similar regulated industry preferred.
- Internal audit certification, MDSAP and IVDR experience preferred.
- Work Experience_
- Minimum 3 years direct experience working in a regulated and certified QMS work environment
- Experience with quality management systems, ISO, Medical Devices/In-Vitro Diagnostics regulations, guidelines, and associated standards
- Skills & Knowledge_
- Highly motivated and self-directed capable of multi-tasking, and able to work with mínimal supervision.
- Strong collaboration skills: builds buy in and knows how to develop stakeholders outside of area of responsibility.
- Attention to detail with excellent written and verbal communication skills.
- Able to interface directly with cross-functional teams.
- Able to develop, review, and maintain Quality associ

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