Quality Assurance Document and Records Control Specialist


Job Description:Who we are looking for: We are currently seeking for a dynamic Quality Assurance Document and Records Control Specialist who will be responsible in ensuring the management, control and compliance of the company’s documents and records related to the company’s Quality Management System in support of the company’s purpose to save lives globally. Document Control · Maintain a centralized system for all documents and records related to the Quality Management System. · Ongoing management of document reviews and updates, owns the document control room. · Revision control and management of documents distributed through the Company including but not limited to batch records · Issues documents and batch numbers to the shop floor, responsible for document compliance and flow through operations. Records Management · Ensures compliance of records and timely accurate filing · Responsible for controlling on-site documents, archiving services, and records retention as per the company’s record retention period requirements. · Responsible for rapid retrieval of records for audit purposes · Plays a role in ensuring accuracy of records, may review batches for operations as needed. · Ensures training records are up to date and compliant. · Maintain confidentiality of critical records and documents throughout the organization. Change Orders · Manages and owns the Document Change Order (DCO) process, issues DCOs and follows up on completion of the change and ensuring training activities are complete. · May provide input or execute on document changes for cross-functional team members by providing expertise and input · Acts as a super user for the QMS software, trains others on the utilization of the software. · May be directly responsible for batch release, supports quality processes (NCRs, CCRs, VR, CAPAs, SCNs, DCOs etc) as needed and participates in training team members on those processes. · May participate in Management Review meetings, audits and projects that require QA input. Education, Work Experience, Knowledge, and Skills: Formal Education: · Post Secondary Degree with a Bachelor of Sciences · Certification in Medical Device Quality Management. · Internal Audit, MDSAP and IVDR compliance certification desired. Work Experience: · Minimum 5 years experience in a Document Control. · Experience in health care, medical device or similar regulated industry · Experience with Quality Management System · Quality Assurance experience an asset. Skills and Knowledge: · Highly motivated and self-directed, capable of multi-tasking and able to work with minimal supervision. · Strong collaboration skills and can work cross functionally. · Attention to detail with excellent written and verbal communication skills. · High level of proficiency with Microsoft Office productivity suite and applications. · Strong work ethic, high level of professional integrity and positive team attitude. · Expresses strong personal values that fit with Response’s vision, values and culture. * 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.Company Description: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. Job ID: 412762
Response Biomedical

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