Position: Quality Manager

Location: Duncan, SC (Onsite)

Duration: Long term Contract

Job Description:

Role name:

Quality Manager

Role Description:

• Support transfer of New Product Introduction to high volume manufacturing and develop quality control plans.• Implement and maintain, as a team member, Standard Operating Procedures, Process flow charts, Process Control Plans, Process FMEA, and Validations.• Manage Non-conformance, CAPA and Complaint (internal and external) processes; ensure root cause analysis and effectively implement robust action plans. Follow-up and verification of CAPAs to ensure no recurrence. Facilitate the closures of these in a timely manner.• Provide Manufacturing Quality Trend Charts/Analysis and suggest/implement continuous improvement practices, including appropriate kaizen events on relevant processes based on trends. Support shin Kaizen events and use Lean manufacturing principles, as and when required. Roll out CDT&R, VOP, DRS, PSP, FMEA- utilize DBS to drive continuous improvements.• Support Supplier Quality Engineer for driving improvements for Supplier related issues (SCARs), work closely with Purchasing/Sourcing departments to select/maintain/drop suppliers list based on their performance.

Competencies:

Production & Manufacturing / Quality

Experience (Years):

10 & Above

Essential Skills:

• Bachelor’s degree in an engineering field (e.g. Biomedical, Chemical, Pharma, Industrial, Mechanical, Systems, Quality, Reliability) or equivalent work experience.• At least 3 years of experience on a manufacturing or relevant environment• Understands and applies Lean Six Sigma tools for problem solving, risk assessment, and process control.• Ability to travel 5-15% (domestic and international)• Proficient with Microsoft Office Tools (including Outlook, Teams, Excel, and Word).

Desirable Skills:

• Knowledge of the following software/systems: Veeva, SAP, Magic (Enovia).• Product line transfers and new product introduction• Customer facing technical writing and conflict resolution.