Supplier Quality Engineer-1400003144W
Description
JOB TITLE: SUPPLIER QUALITY ENGINEER
DEPARTMENT: GLOBAL SUPPLY CHAIN QUALITY – DEPUY IRELAND
REPORTS TO: SUPPLIER QUALITY TEAM LEADER, EXTERNAL MANUFACTURING, EU
JOB PURPOSE:
The Supplier Quality Engineer is responsible for providing quality assurance leadership in the management of External Manufacturers.
________________________________________________________________________________
ORGANISATIONAL INTERFACES:
All Disciplines within the Manufacturing Facility, Outside suppliers and QA related equipment suppliers, and staff across DePuy Orthopaedic sites & J & J companies.
______________________________________________________________________________
MAIN DUTIES & RESPONSIBILITIES:
Provide Quality point of contact for Global Supply Chain with External Manufacturers.
Provide Quality Leadership in support of External Manufacturing Outsourcing programs
Ensure External Manufacturers continue to met DePuy Quality requirements with regard to Supplier Change Request process
Facilitate the completion of the quarterly Suppler Management Committee meeting
Develop supplier capability in risk assessment such as PFMEA
Actively support all defined External Manufacturing Quality Systems goals and objectives.
Represent Quality at Supplier Business Review Meetings
Conduct on-site quality and process assessments at EM suppliers both to approve new suppliers and on an on going basis
Promote continuous improvement and Process Excellence activities within the Global Supply Chain
• Review and approve Validation of new/changed production processes as required
• Design and validate Quality System processes where appropriate (CSV and Inspection Process)
Resolve problems & eliminate constraints to ensure project and supply targets are met.
• Generate Quality metrics on supplier performance and establish measures to monitor quality costs and cost avoidance
Communicate and assure appropriate implementation of Quality Process Specifications (QPS), Quality Control Test Specifications (QCTS), and Raw Material Specifications (RMS) etc.
Ensure effective and timely closure on all Supplier Corrective Action Requests.
Maintain standards of housekeeping & GMP requirements
Represent the Supply Process Quality Assurance function as required by management
Ensure that all Health, Safety and Environmental requirements are fulfilled.
TO ADHERE TO THE COMPANY’S PROCEDURES AS DETAILED IN THE SOP MANUAL
________________________________________________________________________________
Qualifications
KEY COMPETENCIES REQUIRED
• Excellent Communication Skills
• Pro-active approach to work with hands on ability
• Ability to interpret, communicate, and work from drawings and specifications
• Team Player
• Flexible
• Influencing skills
• Validation knowledge
• Highly computer literate
• GMP knowledge
• Excellent project management skills
• Attention to detail
• High work standards
• Excellent planning and organisation skills
• Customer focused
• A minimum of a Bachelor's Degree is required. A Degree in Engineering, Life Science, or related discipline is preferred.
• Minimum 5-6 years’ experience in a Quality or Engineering Function within a Medical Device Company.
• Experience in the medical device, biotech and/or pharmaceutical industry is preferred. Both, FDA and ISO (International Organization for Standardization) regulations knowledge is required FDA CFR Part 820 and/or ISO 13485 knowledge is preferred
• Previous experience of product transfers/start up desired
• Willingness to travel
• Strong in root cause analysis skills
• Strong communication, teamwork, and problem solving skills
• Auditing background is preferred.
• Strong communication, teamwork, and problem solving skills are required.
• Possess knowledge of statistical analysis tools (Minitab SAS preferred).
DESIRABLE:
• Process Excellence – Green/Black belt certification
• ISO 9001 Internal/External Auditor or ASQ Certification as an Auditor.
• Experienced in SPC, Product Validation and ISO 13485.
• Project management experience.
• Knowledge of Orthopaedic products and manufacturing processes
THIS JOB DESCRIPTION IS NOT AN EXHAUSTIVE LIST OF THE JOBHOLDERS RESPONSIBILITIES.
Rev A Oct 2014
Primary Location:Europe/Middle East/Africa-Ireland-Cork-Cork
Organization: Depuy France S.A.S (7888)
Job Function: Quality (Generalist)
Description
JOB TITLE: SUPPLIER QUALITY ENGINEER
DEPARTMENT: GLOBAL SUPPLY CHAIN QUALITY – DEPUY IRELAND
REPORTS TO: SUPPLIER QUALITY TEAM LEADER, EXTERNAL MANUFACTURING, EU
JOB PURPOSE:
The Supplier Quality Engineer is responsible for providing quality assurance leadership in the management of External Manufacturers.
________________________________________________________________________________
ORGANISATIONAL INTERFACES:
All Disciplines within the Manufacturing Facility, Outside suppliers and QA related equipment suppliers, and staff across DePuy Orthopaedic sites & J & J companies.
______________________________________________________________________________
MAIN DUTIES & RESPONSIBILITIES:
Provide Quality point of contact for Global Supply Chain with External Manufacturers.
Provide Quality Leadership in support of External Manufacturing Outsourcing programs
Ensure External Manufacturers continue to met DePuy Quality requirements with regard to Supplier Change Request process
Facilitate the completion of the quarterly Suppler Management Committee meeting
Develop supplier capability in risk assessment such as PFMEA
Actively support all defined External Manufacturing Quality Systems goals and objectives.
Represent Quality at Supplier Business Review Meetings
Conduct on-site quality and process assessments at EM suppliers both to approve new suppliers and on an on going basis
Promote continuous improvement and Process Excellence activities within the Global Supply Chain
• Review and approve Validation of new/changed production processes as required
• Design and validate Quality System processes where appropriate (CSV and Inspection Process)
Resolve problems & eliminate constraints to ensure project and supply targets are met.
• Generate Quality metrics on supplier performance and establish measures to monitor quality costs and cost avoidance
Communicate and assure appropriate implementation of Quality Process Specifications (QPS), Quality Control Test Specifications (QCTS), and Raw Material Specifications (RMS) etc.
Ensure effective and timely closure on all Supplier Corrective Action Requests.
Maintain standards of housekeeping & GMP requirements
Represent the Supply Process Quality Assurance function as required by management
Ensure that all Health, Safety and Environmental requirements are fulfilled.
TO ADHERE TO THE COMPANY’S PROCEDURES AS DETAILED IN THE SOP MANUAL
________________________________________________________________________________
Qualifications
KEY COMPETENCIES REQUIRED
• Excellent Communication Skills
• Pro-active approach to work with hands on ability
• Ability to interpret, communicate, and work from drawings and specifications
• Team Player
• Flexible
• Influencing skills
• Validation knowledge
• Highly computer literate
• GMP knowledge
• Excellent project management skills
• Attention to detail
• High work standards
• Excellent planning and organisation skills
• Customer focused
• A minimum of a Bachelor's Degree is required. A Degree in Engineering, Life Science, or related discipline is preferred.
• Minimum 5-6 years’ experience in a Quality or Engineering Function within a Medical Device Company.
• Experience in the medical device, biotech and/or pharmaceutical industry is preferred. Both, FDA and ISO (International Organization for Standardization) regulations knowledge is required FDA CFR Part 820 and/or ISO 13485 knowledge is preferred
• Previous experience of product transfers/start up desired
• Willingness to travel
• Strong in root cause analysis skills
• Strong communication, teamwork, and problem solving skills
• Auditing background is preferred.
• Strong communication, teamwork, and problem solving skills are required.
• Possess knowledge of statistical analysis tools (Minitab SAS preferred).
DESIRABLE:
• Process Excellence – Green/Black belt certification
• ISO 9001 Internal/External Auditor or ASQ Certification as an Auditor.
• Experienced in SPC, Product Validation and ISO 13485.
• Project management experience.
• Knowledge of Orthopaedic products and manufacturing processes
THIS JOB DESCRIPTION IS NOT AN EXHAUSTIVE LIST OF THE JOBHOLDERS RESPONSIBILITIES.
Rev A Oct 2014
Primary Location:Europe/Middle East/Africa-Ireland-Cork-Cork
Organization: Depuy France S.A.S (7888)
Job Function: Quality (Generalist)