Quality Supervisor

hace 7 días

San Francisco, Heredia, Costa Rica Boston Scientific en Costa Rica A tiempo completo

About the role:

This position operates during night shift hours, supervising Engineering and/or Technician activities that directly or indirectly support production operations or test laboratories. Develops, establishes and maintains quality methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Identifies, coordinates, and assigns project priorities based on business and department objectives. Ensures implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.

You're Responsibilities include:

  • Oversees daily functions and workflow to meet operational objectives, comply with all policies and procedures, assure safety, and achieve effective core metrics performance.
  • Supervises the management of staff, including workforce planning, recruitment, shift schedules, skill and performance assessments, workload distribution, training, corrective action, recognition, and daily direction on work assignments and priorities.
  • Identifies and resolves operational issues and manages addressing non-conformance matters. Recommends and implements process improvements.
  • Serves as internal liaison for team operations, including preparing reports and presentations on functions and performance.
  • Ensures that special projects are completed following established schedules and procedures. Interfaces with cross-functional teams on special projects.
  • Performs other responsibilities as required.

What We're Looking For:

  • Bachelor's degree in engineering (ie: materials, chemical, industrial or similar) could be in process.
  • English Level desired: Intermediate.
  • Experience: 3 years and 1 year in Incoming areas as coordinator or area lead.
  • Or an equivalent combination of education and experience.

Desired knowledge

Technical & Quality Systems Knowledge

  • SAP Quality Module
    : Deep understanding of inspection planning, material master data, and quality notifications.
  • CAPA & Non-Conformity Management
    : Root cause analysis methodologies (e.g., 5 Whys, Fishbone Diagram), CAPA effectiveness checks.
  • Validation Protocols
    : IQ/OQ/PQ processes, statistical tools for correlation studies, GAMP 5 principles.
  • Measurement Systems Analysis (MSA)
    : Gauge R&R, calibration techniques, and metrology fundamentals.
  • Document Control Systems
    : Proficiency in Agile, Trackwise, and document lifecycle management.

Operational & Strategic Skills

  • Area Metrics & KPI Development
    : Designing dashboards, trend analysis, and continuous improvement tracking.
  • Lean Six Sigma
    : Application of DMAIC, waste reduction, and process optimization.
  • Purchasing & Budgeting
    : Vendor evaluation, cost-benefit analysis, and procurement processes for lab equipment.
  • Payroll & Personnel Management
    : Basic HR systems knowledge, timekeeping, and performance evaluation.

Leadership & Training

  • Team Supervision
    : Conflict resolution, delegation, and performance coaching.
  • Training Program Development
    : Creating competency matrices, onboarding plans, and technical training materials.
  • Cross-functional Collaboration
    : Working with R&D, manufacturing, and regulatory teams.

Regulatory & Compliance Knowledge

  • ISO 13485 / FDA 21 CFR Part 820
    : Understanding of medical device regulations and audit readiness.
  • Risk Management
    : FMEA, hazard analysis, and risk mitigation strategies.
  • Document Creation (WI/SOP)
    : Writing clear, compliant procedures and work instructions.

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