Quality Systems Specialist - ISO
- Bridge Global
- 4 - 9 years
- Kochi
- 13 days ago
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Job Description
Key Responsibilities:
- Administer document and record control systems, ensuring version control, traceability, timely reviews, and overall compliance.
- Perform and document software tool validations and revalidations, ensuring alignment with relevant standards.
- Support supplier selection and ongoing monitoring, including maintaining relevant documentation and ensuring supplier compliance.
- Monitor regulatory developments (e.g. AI Act, GDPR), assess gaps, and implement required changes in the QMS.
- Draft, revise, and maintain procedures and work instructions based on regulatory or process changes.
- Prepare input for periodic management reviews, including KPIs, audit outcomes, and improvement actions.
- Support internal audits and coordinate evidence collection and follow-up actions.
- Proactively identify and drive opportunities for quality improvement or operational efficiency.
Qualifications:
- 3+ years of hands-on experience in a quality or compliance role within a regulated industry (medical devices, pharma, health tech, etc.).
- Strong working knowledge of at least one management system (e.g. ISO 13485, ISO 27001, or ISO 9001).
- Excellent English communication skills (written and verbal); all documentation and communication is in English.
- Experience with documentation systems, change management, and audit readiness.
- Comfortable working independently and taking initiative in a remote setup.
Nice-to-Have Certifications (not required):
- ISO Lead Auditor (9001 / 13485 / 27001)
- Regulatory Affairs Certification (RAC) or similar
- Computer System Validation (CSV) training
Key Competencies:
- Excellent written and verbal English communicates clearly and professionally with international clients, both in documentation and direct interactions.
- Strong ownership mindset proactively identifies tasks, follows through independently, and flags issues without needing micromanagement.
- Regulatory awareness and adaptability keeps up with evolving standards (e.g., ISO updates, AI Act, MDR/IVDR) and translates them into practical system improvements.
- Clear and concise technical writing able to draft and revise SOPs, validation reports, and audit evidence to meet compliance requirements.
- Process improvement orientation continuously looks for ways to streamline or strengthen compliance workflows.
- Effective remote collaboration comfortable in asynchronous, cross-border work environments and knows when to escalate or ask for input.
- Hands-on tool proficiency experienced with document control systems (EDMS), QMS platforms, and validation or audit tracking tools.
Job Classification
Industry: IT Services & ConsultingFunctional Area / Department: Quality AssuranceRole Category: Quality Assurance - OtherRole: Quality Assurance - OtherEmployement Type: Full timeContact Details:
Company: Bridge GlobalLocation(s): Kochi+ View Contact
Keyskills: QMS ISO 27001 Medical GDPR ISO13485 ISO 9001 AI Act
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₹ 10-20 Lacs P.A
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