Who we want:
• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
What you will do:
- Work closely with operations and the business functions to ensure quality performance of product and processes.
- Collaborates with Divisional QA, cross-functional and suppliers’ teams to address top quality issues.
- Own identified internal and supplier driven non-conformances and manage the timely closure of NC's within Trackwise. Own or support identified internal CAPAs and manage to timely root cause investigation, implementation and closure.
- Disposition non-conforming product within MRB, issuing NC's as appropriate.
- Communicate & collaborate with suppliers regarding non-conformances, escalating supplier corrective action requests as required.
- Engage in the development and improvement of the internal manufacturing processes for existing products.
- Performs critical assessment of internal and supplier proposed change management activities.
- Performs PPAP activities for supplier changes
- Participates and may lead in the creation and/or review of new or modified procedures.
- Bachelor degree in Science, Engineering or equivalent/ related subject
- Ideally a minimum of 2 or more years experience
- Previous industry experience desired.
- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.
- Understanding of US and International Medical Device Regulations.
- Familiarity with ISO 13485, GDP, GMP desired.
- Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
