Dolphin Sutures
Entry-levelNewQuality

Executive — Quality Assurance

Head Office Full-time 2–5 years Posted 14 Nov 2026
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About the role

Runs the day-to-day quality management system for Futura's sutures and meshes: controlled documents, change control, deviations, CAPA, complaints, training records and batch release documentation. The QA Executive keeps the QMS current and audit-ready under ISO 13485, CDSCO and EU MDR, and makes sure every batch released has a complete and correct record.

At a glance

Department
Quality
Seniority
Entry-level
Location
Head Office
Employment
Full-time
Experience
2–5 years
Qualification
Post Graduate
Reports to
Assistant Manager — Quality
Apply by
30 Nov 2026

What you'll do

  • Issue, control, retrieve and archive SOPs, formats, logbooks and batch records under document control
  • Review batch manufacturing and packing records for completeness and compliance before release
  • Log and track change controls, deviations and non-conformances; coordinate investigations and CAPA with the departments concerned
  • Record customer complaints, support investigations and track responses to closure
  • Plan and take part in internal audits; follow up findings to closure
  • Maintain training matrices and records; run GMP and SOP training sessions
  • Support supplier qualification, incoming material approval and supplier audits
  • Support process, equipment and cleanroom validation documentation
  • Prepare quality data for management review: trends of deviations, complaints, CAPA and audit findings
  • Support notified-body, CDSCO and customer audits: documents, records and responses

How success is measured

  • Batch records reviewed and released on time
  • Change controls, deviations and CAPA closed on time
  • Audit observations on documentation and QMS
  • Training completed as per the training matrix
  • Document control errors (wrong version in use, missing records)

What we're looking for

Qualifications & experience

  • B.Sc. / M.Sc. (Chemistry, Microbiology or Biotechnology), B.Pharm / M.Pharm or B.E. (Biomedical)
  • Experience: 2–5 years

Must-have skills

  • Quality assurance, document control, change control, CAPA, deviation, batch record review, ISO 13485

Competencies

  • Attention to detail
  • Integrity
  • Follow-through
  • Clear writing
  • Working across departments

Good to have

  • Internal auditor, EU MDR, CDSCO, complaint handling, validation, medical device

Working conditions

  • Travel: Plant-based; occasional supplier visits
  • Conditions: Office and plant areas; cleanroom entry with gowning when required

Compliance

  • ISO 13485:2016, CDSCO Medical Devices Rules 2017, EU MDR 2017/745 and GMP
  • Good documentation practice and data integrity (ALCOA+)
  • Independence of quality decisions
  • Company code of conduct

What happens after you apply

  1. Apply onlineSend your details and résumé. It takes about two minutes.
  2. HR reviewOur HR team reads every application for this role.
  3. InterviewsIf your profile matches, we contact you to arrange the interviews.
  4. OfferThe successful candidate receives a written offer.

About Dolphin Sutures

Dolphin Sutures, a Futura Surgicare Pvt. Ltd. company, makes surgical sutures, meshes and wound-closure devices used in operating theatres across India and abroad. We hire for ownership, clarity and care.

About us · All open roles

Reference REQ0059