We are looking for a Director Supplier and Production Quality.
This position will focus on improving product quality through data analysis,
investigation, issue resolution and collaboration with both internal and external parties. This person will be responsible for driving the non-conforming material process and root cause investigation through coordination with engineering & R&D organizations.
You will be responsible for making final decisions on production and supplier quality along with ensuring NPI, engineering, supply chain and fulfilment as well as production effective achievement of quality and compliance objectives.
In the role of Production & Suppliers Quality director you will oversee iTero production in various global facilities; youll also be managing suppliers and contract manufactures for iTero from around the globe.
In this role, you will:
Drive product quality improvements in production and with suppliers
Manage a team of quality engineers & the QC Dept.
Manage the NCM and MRB processes.
Lead analysis of defects data (NCM, RMA and DOA)
CAPA/ SCAR creation / resolution and maintain records as specified by the quality system
Lead QC team and drive incoming inspection improvements, such as direct- to- stock, reduction of MRB and non-conforming material inventory.
Interface with other functions on supplier related defects
Conduct root cause analysis on product quality issues, identify trends, and communicate with Engineering/ R&D on a regular basis.
Be responsible to oversee that Operations are working according to released and validated work instructions to ensure that a device conforms to its specifications.
Be responsible for process- related Validations across the company process, support SW, mold, jigs
Ensure the creation of accurate, complete and timely records and DHRs
Set the yearly suppliers audits plan and execute with the team
Be responsible for evaluating current suppliers, approving new suppliers and disqualifying suppliers
Support the introduction of iTero production lines in other facilities around the globe and with external contract manufacturers.
Work with our Global on the integration and harmonization of Purchasing controls and Production and process controls related SOPs, suppliers audits and supporting IT systems.
Support PFMEA creation and update and any other process and suppliers' risk- related activities
Additional responsibilities:
Be aware of and comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/ position.
Complete all planned Quality & Compliance training within the defined deadlines.
Identify and report any quality or compliance concerns and take immediate corrective action as required.
Support external bodies audits on- site
Perform internal audits.
Requirements: B.Sc. in Engineering (Electronics, Mechanics, Materials, Chemistry, Biomed) or equivalent
At least 15 years of experience in quality positions in medical device industry
Experience in leading supplier and production quality in active medical device.
Proven experience participating in notified body/FDA audits.
Experience in working with suppliers and subcontractors and contract manufacturers in multiple countries
At least 10 years of experience in a managerial role
Deep understanding of medical device regulatory requirements including specifically in regards toa Purchasing controls and Production and Process Controls
Proven qualification in root cause investigation methods
MDR implementation experience is an advantage.
Lead Auditor Certification from an accredited organization - Advantage
Working knowledge in statistical tools (MSA, Cpk); Six Sigma green belt is an advantage.
This position is open to all candidates.