Sr Quality Manager
El Coyol, Alajuela, Alajuela, Costa Rica
hace 2 días

Responsibilities may include the following and other duties may be assigned.

Daily Policy Deployment Tiermeetings and Gemba walks

Communication with Global Qualityand peers (Alignment of the site to the Business Unit / Corporate Requirements)

Internal Customer Relations

External Customer Relations

Attendance and engagement withsite leadership.

Oversight and engagement withmanufacturing personnel.

Inspection and Quality Releaseoversight

CAPA Management

Engagement and management of siteQuality Improvement Plan.

Engagement on plant strategicobjectives as prioritized

Quality Begins with Me Program(Model Behavior)

Part Transfers Quality Project

Hiring and team building tocreate a World Class Quality Organization

Department Cost Center andFinance Reviews

Preparation for, and participationin QSR, MOR, Monthly Staff Meeting, etc

Site communications participation(Department, Plant, Safety, Quality, etc)

Preparation and participation ofData analysis and Management Reviews, including use of appropriate statisticaltechniques.

Participation and engagement inCost Down projects

Accountable for handling / Disposition of Non-conforming Products

Accountable for establish qualitysystem initiatives for ensuring compliance to regulatory requirements

Participation and engagement inPMO / Continuous improvement projects and activities

Audit / Regulatory Inspectionleadership

Inputs and approvals as neededfor Quality System components (Agile, Trackwise, Change Control, etc)

Support validation activities asrequired

Must Have : Minimum Requirement

  • Mid to Large Manufacturing facility on site quality leadership experience
  • A four-year college degree in one of the engineering disciplines or a related field with 5 plus years of direct experience.
  • 3+ years of progressive leadership experience in functional area or related field
  • Knowledge and application of industry standards and regulatory requirements (including but not limited to : ISO 13485, ISO 14971, MDD 93 / 42 EEC, PMDA, CMDR, RDC 59, TGA, and 21 CFR Part 820).
  • Demonstrated track record of Regulatory Inspection management.
  • Experience implementing systems that drive compliance with all requirements.
  • Extensive experience with successful hiring and team building
  • Nice to Have

  • CNC or automated machining environment experience
  • Experience manufacturing finished medical devices
  • Medical Device cleaning validation and management experience
  • Cleanroom processing and packaging experience
  • Advanced degree (e.g., MBA).
  • Quality certification (CQM or CQE or equivalent).
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