Supervisor, Quality at Boston Scientific Corporation Malaysia

La Asunción, Cantón de Belén, Costa Rica -

Full Time

Start Date

Immediate

Expiry Date

06 Feb, 26

Salary

0.0

Posted On

08 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management, Process Improvement, Team Supervision, Training Program Development, Cross-functional Collaboration, Risk Management, Document Control Systems, Lean Six Sigma, CAPA Management, Measurement Systems Analysis, SAP Quality Module, Validation Protocols, Area Metrics Development, Purchasing & Budgeting, Conflict Resolution, Performance Coaching

Industry

Medical Equipment Manufacturing

Description

Oversees daily functions and work flow 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 and pay differentials, 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. 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. 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. 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. 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. 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.

Responsibilities

The Supervisor, Quality oversees daily functions and workflow to meet operational objectives and ensure compliance with policies and procedures. They supervise staff management, resolve operational issues, and implement process improvements while serving as an internal liaison for team operations.