08 - Specialist, Operations Quality (Medicaldevices)

General Overview

Functional Area:  Quality (QUA)
Career Stream:  Operations Quality (OPQ)
Role:  Specialist (SPE)
Job Title:  Specialist, Operations Quality
Job Code:  SPE-QUA-OPQ
Job Level:  Band 08
Direct/Indirect Indicator:  Indirect

Summary

Quality Specialist is responsible for dealing with the three major phases of Quality Management - Quality Planning/Prevention, Corrective Action, and Continual Improvement. Quality specialist will lead process/procedure definition, and maintain a continuous flow of high quality products to our customers.

Contract Manufacturing, statistics, ISO 13485, Validation IQ, OQ, PQ, MSA, Kappa Test, Risk Management, Lean Manufacturing, Auditor ISO 13485,cleaning processes, SMT Process

Detailed Description

Performs tasks such as, but not limited to, the following:

• Lead the team to handle all quality excursions independently, and take effective actions on time
• Oversee the product & material quality from NPI to mass production
• Develop the quality control plan for respective area (material/process/product)
• Monitor and report quality KPI for internal (factory) and external (customer)
• Drive continuous improvement to benefit customer, CLS and supplier.
• Develop and maintain internal quality system, procedures, work instructions and workmanship standards
• Lead process/product/system/supplier audit and improvement actions follow up.
  • Industry standards (e.g. ISO)
  • Compliance audit
  • Safety audit etc.
• Follow up the EC(Engineering Change), SPCN(Supplier Process Change Notification) to ensure the implementation of changes is timely and accurate (initiated both externally and internally)
• Coach junior quality staff to improve their quality knowledge.
• Accomplish the jobs assignment from the superior and participate in the quality strategy deployment.

Knowledge/Skills/Competencies

• Strong knowledge of quality tools, ISO and IPC standards and processes
• Knowledge of software and its uses in generating reports capturing data presenting data in an understandable format
• Strong knowledge of  product and manufacturing processes
• Knowledge and understanding of the business unit and how decisions impact customer satisfaction product quality ,on-time delivery and profitability of the unit
• Knowledge of quality tools such as FMEA, PMP, SPC, 8D methodology, etc. 
• Knowledge of Six sigma and Lean Kaizen.
• Ability to effectively communicate with a wide variety of internal and external customers

Physical Demands

• Duties of this position are performed in a normal office environment.
• Duties may require repetitive manual movements (e.g., keyboarding), carrying, pushing or pulling light objects, (under 5 kg.), carrying, pushing or pulling heavy objects (over 5 kg.), crouching, climbing
• Sustained visual concentration on small areas, such as monitors, screens, precise eye/hand coordination, sustained visual concentration on numbers, legal documents

Typical Experience

• 4 to 6 years in a similar role or industry.

Typical Education

• Bachelor's degree in related field, or consideration of an equivalent combination of education and experiency.
• Educational requirements may vary by geography.

Notes

This job description is not intended to be an exhaustive list of all duties and responsibilities of the position. Employees are held accountable for all duties of the job. Job duties and the % of time identified for any function are subject to change at any time.