Engineer/Senior Engineer, Quality Management System
Location
Bangalore | India
Job description
Biofourmis brings the right care to every person, no matter where they are. The company's AI-driven solution collects and analyzes patient data in real time and identifies shifts that require proactive interventions. This vital innovation provides people everywhere with connected access to hospital-level services, virtual provider networks for remote care, and life-changing clinical trials—all without leaving their homes. Trusted by leading health systems, payers, biopharma companies and patients alike, Biofourmis' connected platform improves patient outcomes, prevents hospital readmissions, accelerates drug development, and closes critical gaps in care—ultimately making science smarter, healthcare simpler, and patients healthier. Biofourmis is a global technology company enabling care delivery, with headquarters in Boston and key offices in Singapore and India.
Engineer/Senior Engineer, Quality Management System QMS | Bangalore
Job Summary: Responsibilities: - Monitor and maintain the effectiveness of established Quality Management System processes
- Maintain and implement Quality Systems SOPs and Wis, including revision of procedures for improvement
- Maintain and manage the eQMS platform
- Conduct training related to Quality Systems
- Schedule and perform audit (internal and supplier) activities including management of internal audit team, pre-audit planning, audit execution and evaluation and post-audit follow-up and recommendations
- Support 3 rd party audit activities including pre-audit planning, audit readiness, and post-audit follow up with external auditor
- Function as Document Controller for the initiation, revision, release and distribution of documents
- Investigate NC, CAPA, Complaints, quality-related issues as assigned
- Execute and implement quality-related improvement activities
- Collaborate with Human Resources and HODs to maintain the currency and relevancy of the Department Training Matrix
- Monitor, maintain, and trending of quality processes (e.g., CAPA, Complaints, NC, Supplier Performance, etc.)
- Support/perform incoming, in-process and outgoing processes, ensuring product meets specification
- Other jobs assigned by Supervisor
Authorities: - Creation, revise and review QMS documents
- Approval of records and logs for release on eQMS platform
- Review and approval of supplier's artwork against internal artwork specification
- Approval of the investigation and outcome of quality processes (CAPA, NC, complaint, internal audits, etc)
- Approval of internal audit findings
- Plan the internal audit schedule for Biofourmis Singapore
- Endorse distribution of internal documents to external parties
Experience / Training: - Good understanding of the Quality System Requirements, for example ISO 13485:2016 and 21 CFR Part 820
- Knowledge of ISO 14971:2019 Medical devices – Application of risk management to medical devices
- Hands-on experience in ISO 13485 and QSR implementation is an advantage
- Experience in conducting/leading Quality System audits
- ISO 13485:2016 Internal/Lead Auditor Certification is an advantage
Education: - Preferably Bachelor's degree or equivalent in Science or Engineering
Skills: - Ability to manage and drive a cross-functional team to accomplish the various QS-related tasks
- Ability to present and communicate information clearly and effectively
- Attention to detail
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