Quality Engineer, DePuy Synthes

Job Description

We are searching for the best talent for Quality Engineer to join our DePuy Synthes Quality organization located in Palm Beach Gardens, FL.

Key Responsibilities

• Provides comprehensive quality support for daily manufacturing activity.
• Manages the initiation, containment, investigation, disposition and closure of Non-Conformances in the PBG and WPB MAKE Sites.
• Performs and/or supports CAPA records, including risk assessment, root cause investigation, corrective and preventive actions and effectiveness monitoring.
• Utilizes industry and process excellence standards on a moderately complex level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO).
• Addresses or escalates product and process complaints.
• Evaluates contract manufacturer performance metrics and supports management reviews.
• Conducts audits of all quality system categories to assess compliance to process excellence standards.
• Implements comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, demonstrating continuous improvement to man.
• Facilitates technical issues for manufacturing processes that are to be transferred to satellite facilities.

Qualifications

• A minimum of a Bachelor’s degree is required. Degrees in Engineering, Life Science, or related field is preferred.
• A minimum of 1-2 years of relevant work experience or internships.
• Experience working in regulated industries.
• This position will require relevant experience working in manufacturing/operations.
• In-depth knowledge of product/process Risk Management (MDSAP, MDD, MDR, FDA and ISO standards).
• Advanced knowledge of Six Sigma methodologies.
• Understanding of the NPI (New Product Introduction) process.

Preferred Skills

• Customer Centricity
• Data Savvy
• Document Management
• Execution Focus
• Good Automated Manufacturing Practice (GAMP)
• Issue Escalation
• Lean Supply Chain Management
• Process Control
• Process Improvements
• Quality Control (QC)
• Quality Services
• Quality Standards
• Quality Systems Documentation
• Application
• Supervision
• Supply Planning
• Technologically Savvy