Senior Quality Assurance Specialist

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 currently seeking for a dynamic Senior Quality Assurance Specialist who will be responsible in ensuring that Response meets product and processes quality standards by providing ongoing customer satisfaction and ensuring that we support our 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., SOR 98/282, ISO 13485:2016, MDSAP, IVDR, US FDA Regulations and country specific Medical Device amendment requirements).
• Identifies gaps in the QMS, develops and drives cross-function implementation of corrections and process improvements, ensuring an effective balance of compliance and efficiency.
• Provides guidance and training to the company related to QMS processes and procedures.
• Drives cross functionally, the completion of non-conformances (NC), CAPAs, Variances (VR), Reworks (RW) and all associated investigations ensuring root cause analysis, action plans and effectiveness checks are completed.
• Manages the CAPA management process by ensuring that CAPA investigations/implementations are performed compliantly and closed in a timely manner.
• Performs the risk assessment analysis and enables team members to perform risk assessments for all applicable processes.
• Participates in the Management Review meetings and may organize and develop the management review report.
• Participates and drives the execution of the audits up to CAPA closure.
• Participates in the projects to provide QA inputs, expertise and support needed.
• Supports the Supplier Management process by ensuring that the qualification, evaluation and monitoring of supplier’s activities are assessed based on their ability to supply products or services in accordance with established requirements and procedures.
• Ensures all the validation/verification/stability protocols, summary reports and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria are properly reviewed, documented and completed on-time.

Quality Operations

• Ensures the timely completion of NCs, VRs, reworks RWs, risk assessments and root cause analyses related to operations.
• Initiates the NCs when deviations in the materials, inspections, documentation, or procedures is/are found. Collaborates with operations to investigate the NC for root causes and for the appropriate correction, corrective, or preventive actions to apply.
• Ensures the accurate status labeling and disposition of incoming materials, in-process materials, and products throughout the operations area.
• Coordinates and ensures the compliance with training programs including driving the development of new training programs and re-training compliance.

Document I Records Management and Change Control

• Acts as a super user for the QMS software, trains others on the utilization of the software.
• Maintains a centralized system for all documents and records related to the QMS.
• Manages and owns the Change Control Process and Significant Change Control Process.
• Ensures compliance on revision control and management of documents distributed through the Company including but not limited to batch records.
• Supports the control of on-site documents, archiving services, and records retention as per the company’s record retention period requirements.
• Supports the archiving services with the third- party supplier and ensures rapid retrieval of records for audit purposes.

Education, Work Experience, Knowledge, and Skills:

Formal Education:

Minimum BSc in a scientific discipline.

Work Experience: 

• Minimum 8 years direct experience working in a regulated QMS (experience in analytical testing/ medical device industry is preferred).
• Experience with quality management systems, ISO, FDA regulations, guidelines and associated standards.
• Experience in health care, medical device or similar regulated industry.

Skills and Knowledge:

• Exhibit detailed working knowledge of the medical device industry and the regulatory environment in which the business operates.
• Highly motivated and self-directed, capable of multi-tasking, and able to work with minimal 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 associated metrics and manage quality audits.
• Strong problem identification and problem resolution skills.
• High level of proficiency with Microsoft Office productivity suite and database applications.
• Strong work ethic, high level of professional integrity, and positive team attitude.
• Ability to confidently interact with all levels of management.
• Ability to independently act to assure quality and regulatory compliance.
• Expresses strong personal values that fit with Response’s vision, values, and culture.

The starting salary for this position ranges from $66,000 to $78,000 annually, depending on the candidate’s experience and qualifications. Our salary structure is aligned with market standards and is finalized considering factors such as job-related expertise, skills, education, and experience.

Please note that this position is only available to candidates who are authorized to work in Canada.

 *We regret that relocation will not be provided.

* While we appreciate the interest of all applicants, only those candidates selected for interview will be contacted.

We’re committed to a diverse and inclusive workplace. We welcome applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. All employment decisions are based on business needs, job requirements and individual qualifications.