Executive / Assistant Manager - Quality Assurance

Qualification:

Job Summary:

• We are seeking a highly skilled and experienced

  Quality Assurance (QA) professional

  to serve as

  Assistant Manager

  for QA operations supporting IVD manufacturing and compliance activities at

  Labsystems Diagnostics Oy

  .
• This role will lead

  Change Control processes

  , assist in

  ISO 13485 QMS audits

  , and support a range of

  quality system functions

  , including CAPA, document control, training, and cross-functional quality initiatives.
• The ideal candidate will have strong domain expertise in IVD and be confident in supporting both

  internal quality improvement

  and

  external regulatory expectations

  , including IVDR compliance.

Key Responsibilities:

• Manage and lead the

  Change Control system

  , ensuring accurate documentation, timely follow-up, and cross-functional impact assessment.
• Support

  internal and external audits

  , including ISO 13485, Notified Body (NB), and customer audits.
• Drive

  CAPA processes

  , root cause analysis, effectiveness checks, and preventive actions.
• Collaborate with cross-functional teams (RA, R&D, Manufacturing, Service) to maintain and improve QMS effectiveness and regulatory compliance.
• Assist in preparation, review, and maintenance of

  SOPs

  ,

  Quality Plans

  ,

  Risk Management files

  , and

  Technical Documentation

  .
• Monitor QMS metrics and generate quality performance reports for management review.
• Ensure

  Document Control

  procedures are followed for all quality and regulatory documents.
• Support

  training coordination

  , maintaining training matrices and ensuring compliance with competency requirements.
• Contribute to

  supplier quality oversight

  , including evaluation, qualification, and performance monitoring.
• Assist in

  IVDR transition activities

  , particularly in areas impacting QA documentation and audit readiness.

Required Skills & Experience:

• 6-8 years of hands-on experience in Quality Assurance in the

  IVD or medical device industry

  .
• Strong knowledge of

  ISO 13485:2016

  , with practical experience in managing QMS elements such as Change Control, CAPA, and Document Control.
• Demonstrated experience in

  audit preparation, participation, and follow-up

  for regulatory and certification audits.
• Familiarity with

  risk-based approaches

  , complaint handling inputs, and quality planning.
• Excellent communication, documentation, and problem-solving skills.
• High level of ownership, attention to detail, and continuous improvement mindset.