Production and QA Head ( Medical Devices)

Production Lead

Key Responsibilities

Production Management

• Plan and execute

  daily/weekly/monthly production schedules

  aligned with demand forecasts.
• Manage

  assembly, integration, and testing

  of active medical devices to meet quality and delivery commitments.
• Ensure

  cleanroom operations

  and adherence to production SOPs.
• Drive

  equipment qualification and process validation (IQ, OQ, PQ)

  at the production floor.
• Monitor and improve key production metrics:

  yield, first-pass success rate, downtime, scrap rate, and productivity

  .
• Ensure timely availability of

  materials, spares, and consumables

  by coordinating with supply chain.
• Support

  design transfer to production

  , ensuring prototypes scale effectively into full manufacturing.

Production-Level Compliance & Quality

• Ensure production floor compliance with

  ISO 13485, GMP, and device master record (DMR)/device history record (DHR)

  requirements.
• Oversee

  in-process quality checks

  , functional testing, and batch release readiness.
• Implement

  CAPA, change control, and training programs

  for production teams.
• Collaborate with QA to ensure timely

  audit readiness

  , focusing on production-level practices.
• Maintain production documentation, validation records, and traceability.

Team & Leadership

• Supervise production staff, technicians, and line engineers.
• Train and mentor the production team on

  good documentation practices (GDP), cleanroom behavior, and regulatory compliance

  .
• Drive a

  culture of continuous improvement

  in manufacturing operations.
• Act as the point person for

  production issues

  during customer visits, audits, and inspections.

Qualifications and Experience

• Bachelor’s degree in

  Engineering (Biomedical, Mechanical, Electrical)

  or equivalent.

• 5+ years of experience

  in medical device production/manufacturing, preferably active devices.
• Strong knowledge of

  production planning, assembly/test operations, and GMP compliance

  .
• Hands-on experience with

  process validation, equipment qualification, and cleanroom manufacturing

  .
• Familiarity with ISO 13485:2016, FDA QSR (21 CFR Part 820), EU MDR, and ISO 14971.
• Proven ability to

  lead teams

  , solve production problems, and ensure regulatory compliance in manufacturing.

Key Competencies

• Production floor leadership with

  strong operational discipline

  .
• Knowledge of

  lean manufacturing and continuous improvement

  methodologies.
• Ability to balance

  throughput, cost control, and compliance

  .
• Strong interpersonal and problem-solving skills to manage cross-functional challenges.