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 Quality Assurance Associate 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
- Responsible in the qualification, evaluation and monitoring of suppliers based on their ability to supply products or services in accordance with established requirements and
- Supports Supplier Management process by initiating SCARs to resolve vendor and material issues, if necessary.
- Proficient user of the QMS Software Doc control and training
- Supports quality and regulatory training sessions, ensuring timely filing of documentation of training effectiveness.
- Supports batch review and release through ensuring Good Documentation Practices is followed, if necessary.
- Prepares, supports, and participates in quality and regulatory audits, assuring readiness.
Quality Operations
- Responsible on the quality inspection and timely release of incoming materials other than dock to stock (DTS) materials or materials requiring QC testing prior to release.
- Ensures the accurate status labeling and disposition of incoming materials, in-process materials, and products throughout the operations area.
- 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.
- Identifies gaps in the QMS, develops and drives cross-function implementation of corrections and improvements.
Records Control
- Responsible for filing QMS documents including batch and training
- Retrieves and ensure compliant and timely filing of records, supporting document control.
Education, Work Experience, Knowledge, and Skills:
Formal Education:
- Post Secondary Degree
Work Experience:
- Minimum 1 year experience in health care, medical device, or similar regulated industry.
- Some experience working in an environment regulated by ISO, FDA regulations, guidelines, and associated standards.
Skills and Knowledge:
- Must be able to communicate effectively in English both written and
- Ability to make general mathematical
- Attention to detail with good written
- Medium level of proficiency with Microsoft Office productivity suite and database applications.
- 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.
- Able to interface directly with cross-functional
- Strong work ethic, high level of professional integrity, and positive team attitude.
The starting salary for this position ranges from $47,000 to $50,000 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.