Supplier Quality Eng.

Supplier Quality Eng. will be responsible for supplier quality engineering activities supporting production, medical device release processes, analyze and resolve non-conforming in the production line, in particular supplier quality problems by conducting audits, analyzing defect trends and leading improvement projects. This positions Partners with QA, Engineering, Supply Chain and supplier’s functions to ensure quality and compliance of manufactured products.

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  capability  of consistently meeting  requirements. Projects may include process analysis, value stream mapping, process capability and throughput analysis 

·  Drive “Zero Defect” mentality within the supply base.

Competence and Authority

·  Risk management

·  Labeling 

·  Customer Complaints, RMA, Vigilance

·  Non-conforming product

·  Supplier Evaluation and Approval

·  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

Nice to Haves

·  Understanding of project management %28experience preferred%29

·  Knowledge of various quality system methodologies 8D, Lean, 5 Why’s, Pareto Analysis, Six Sigma, 8-D, DFMEA,

·  PFEMA, PPAP, etc. preferred