Supplier Quality Engineer

Responsibilities

 · Manage and implement annual Supplier audit plan, Audits Response, support regulatory audits, Audit and certify suppliers to required standards 

· Supports contract manufacturers and supplier quality activities and monitors production and compliance key process indicators. 

· Supports new product introduction activities including process, equipment, SW and environment validations, production risk management, control
plans component qualification and staff training.

 · Analyze complaints and prepare response to related bodies. · Analyze production Yield & cost of Quality.

 · Overview follow up and guidance of routine QA/ QC activities such as CAPA, MRB, RMA, SCAR, incoming inspection, in process inspection,
final inspection, product release.

 · Defines and implement policies and procedure for inspections, rejects& process Validation including IQ, OQ & PQ. 

· Work with Purchasing to ensure supplier performance is regularly reported and that appropriate and timely corrective actions are implemented 

· Maintain and update critical supplier audit system and schedule

 · Conduct supplier audits to drive process standardization, waste elimination, and continuous improvement 

· Establish specific short / long term supplier quality goals 

· Champion problem solving and root cause analysis activities with suppliers and customers to eliminate recurrence of non‐conformances

 · Work to resolve supplier technical issues in a timely manner to ensure continuity of supply

 · Develop long‐term supplier relationships and generate and implement cost reduction ideas 

· Aide Manufacturing in the evaluation and qualification of new supplier materials following a defined new product development process

 · Strategically lead supplier performance improvement projects in an effort to increase the supplier capabilitys. 

Projects may include process analysis, value stream mapping, process capability and throughput analysis 

 · Risk management 

Labeling · Customer Complaints, RMA, Vigilance · Non-conforming product · Supplier Evaluation and Approva 

Qualification 

At least 5 years related experience in medical device and training in design & development, manufacturing environment & Suppliers management;
Knowledge in MDD, MDR, QSR, ISO13485, and ISO14971. 

· Understanding of process validation principles, including experience with master validation plans, installation qualifications, operational qualifications, process qualifications, and test method validations. 

· Strong knowledge in CAPA, NCMR, RMA, Labeling, Rework and Batch release processes.

 · Strong written and verbal communication skills

 · Advanced computer skills using Microsoft Office applications

 · Strong problem-solving skills

 · Strong organizational skills