Quality Systems Specialist
Job Summary
Job Description
The Quality System Specialist will be responsible for supporting AliveCor’s Quality Management System (QMS). This includes managing QMS-related documents and records, such as product design history files, CAPAs/NCs, training, and audits. The specialist will also support internal and external audits and quality improvement initiatives. Responsibilities include maintaining the electronic document control database, managing SOPs, assisting in compiling design inputs, supporting new product development teams, managing training records, assisting CAPA and NC owners, managing the Approved Supplier List (ASL), preparing documents for Management Review meetings, and supporting audits. This role requires ensuring compliance with FDA QSR, ISO 13485, and EUMDR.
Must have:
- Bachelor's degree in Science or Engineering
- 5+ years experience in QMS management
- Knowledge of FDA QSR, ISO 13485, and EUMDR
- Experience with document management systems
Good to have:
- Experience with Master Control
- Good Documentation Practices knowledge
- Strong communication skills
Perks:
- Hybrid working model
- Flexible vacation policy
- Maternity / Paternity Leave/ Adoption/ Commissioning leave
- Generous Medical Benefits
- Metro connectivity from office
- Supportive and collaborative team
7 skills required
Job Details
Why join AliveCor?
At AliveCor, we imagine a healthier world powered by access to personalised intelligent information. Heart disease kills more people than anything else in the western world, including all cancers combined. We're on a mission to be the world’s heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical EKG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software, hundreds of thousands of users have taken more than 100-million heart health measurements and counting.
The Opportunity: AliveCor seeks a Quality System Specialist join this exciting start-up that is changing the face of mobile health. In this role, you will be responsible for the hands-on, day-to-day support of AliveCor’s Quality Management System (QMS) to ensure compliance to company procedures, FDA QSR, ISO 13485, EUMDR and other regulatory standards. Main duties include the processing and maintenance of all QMS-related documents and records, related to product design history files, CAPAs/NCs, training, external standards, suppliers, audits, and calibration. Additional responsibilities include supporting internal and external audits and quality improvement initiatives. This role requires the candidate to be based out of our office in Bangalore, India.
Responsibilities:
- Support the Quality Systems Manager in the management of AliveCor’s QMS
- Maintain AliveCor’s electronic document control database to ensure the efficiency of AliveCor document control process and compliance to AliveCor and regulatory standards
- Manage creation, revision, and obsolescence of SOPs, Work Instructions (WRKs), and forms in accordance with document control procedures and assist AliveCor team members with processing of urgent documents, reminders, and status updates, as needed
- Assist in compiling and organizing design inputs, risk management files, verification/validation reports, and other technical documentation.
- Support new product development teams in maintaining robust design controls by verifying that Design History Files (DHFs) accurately reference the current document numbers, revisions and associated Quality Records.
- Manage training records and assignments for quality-controlled procedures, including coordinating document revisions, running overdue training reports, sending overdue reminders, administering quizzes, facilitating password resets, and maintaining records per retention policies.
- Assist CAPA and NC owners with ensuring completeness of records. Prepare monthly meeting metrics, maintain logs, and send reminders for required activities (i.e. due dates and effectiveness checks)
- Manage and maintain the Approved Supplier List (ASL), ensure documentation is up-to-date for all suppliers, and coordinate activities related to supplier qualification, periodic re-evaluation, and audits in accordance with the Supplier Control procedures.
- Assist in the preparation of documents/metrics for Management Review meetings and maintain meeting records
- Support internal, supplier, and regulatory audits by ensuring documentation readiness, process adherence, compiling required deliverables, and tracking post-audit findings through to timely corrective action and closure.
- Maintain comprehensive calibration logs, coordinate timely calibration activities with internal teams or external metrology vendors, ensure accurate documentation of all measuring and monitoring equipment, and proactively verify compliance with established calibration schedules and quality standards.
- Support the integration of new requirements into the Quality Management System and applicable procedures to ensure ongoing compliance.
- Coordinate, manage, and lead programs related to quality improvement or business objectives as assigned by Quality System Manager and assist other functional areas, as needed
Requirements:
- Bachelor’s degree in Science or Engineering
- 5+ years of document control, QMS management, supplier management, and/or training administration function in the medical device or other regulated industry
- Working knowledge of FDA QSR (21 CFR 820), ISO 13485, EUMDR and applicable standards (ISO 14971, IEC 62366, etc.).
- Prior experience with electronic document management systems and/or learning management systems (LMS). Experience with Master Control is a plus
- Knowledgeable of Good Documentation Practices to perform and execute job responsibilities with a high level of accuracy
- Demonstrated ability to communicate effectively with internal and external customers and develop expertise to provide improved assistance
- Have good communication skills, both written and verbal. Strong editorial and technical writing skills a plus
- Excellent organisational skills along with strong attention to detail
- Ability to work both independently and collaboratively with small, cross-functional teams
- Highly proficient with Microsoft Office Suite and Adobe Acrobat
Perks and benefits:
We strive to make your life outside work as smooth as possible while you're at work, and we offer a long list of benefits to make that happen.
- Hybrid working model
- Flexible and generous vacation policy
- Maternity / Paternity Leave/ Adoption/ Commissioning leave
- Generous Medical Benefits: Above market family floater medical insurance coverage including both parents or parents-in-law
- Metro connectivity from office
- A supportive, collaborative group of people who understand that success depends on the team
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