Supplier Quality Engineer-1415588W
Description
JOB DESCRIPTION
JOB TITLE: SUPPLIER QUALITY ENGINEER
DEPARTMENT: GLOBAL SUPPLY CHAIN QUALITY – DEPUY IRELAND
REPORTS TO: SUPPLIER QUALITY MANAGER, EU DIRECT MATERIAL
JOB LOCATION: CORK
BAND: 25
JOB PURPOSE:
The Supplier Quality Engineer is responsible for providing quality assurance leadership in the management of suppliers. Responsible for providing supplier quality engineering support and conducting assessments for activities related to supplier selection and evaluation, supplier performance, and strategic procurement.
________________________________________________________________________________
ORGANISATIONAL INTERFACES:
All Disciplines within the Manufacturing Facility, Outside suppliers and QA related equipment suppliers, and staff across DePuy Synthes Orthopaedic sites & J & J companies.
______________________________________________________________________________
MAIN DUTIES & RESPONSIBILITIES:
Conduct on-site quality and process assessments at suppliers when required to do so.
Liaising with the Manufacturing and Quality engineers in manufacturing, in assessing and addressing material quality issues.
Ensure effective and timely closure on all Supplier Corrective Action Requests.
Ensure suppliers continue to met DePuy Quality requirements with regard to Supplier Change Request process
Facilitate the completion of the quarterly Suppler Management Committee meeting
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)
• Provide support for the introduction of new components and component changes through the First Article process.
• Develop supplier capability in risk assessment such as PFMEA
Resolve problems & eliminate constraints to ensure project and supply targets are met.
Communicate and assure appropriate implementation of Quality Process Specifications (QPS), Quality Control Test Specifications (QCTS), and Raw Material Specifications (RMS) etc.
Maintain standards of housekeeping & GMP requirements.
Represent the Supply Process Quality Assurance function as required by management.
Provides guidance to Purchasing, Engineers and stakeholders in applying supplier quality system requirements.
Ensure that all Health, Safety and Environmental requirements are fulfilled.
TO ADHERE TO THE COMPANY’S PROCEDURES AS DETAILED IN THE SOP MANUAL
________________________________________________________________________________
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
Qualifications
QUALIFICATIONS & EXPERIENCE
ESSENTIAL:
• 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.
Primary Location:Europe/Middle East/Africa-Ireland-Cork-Cork
Organization: Depuy (Ireland) Limited (7386)
Job Function: Quality (Eng)
Description
JOB DESCRIPTION
JOB TITLE: SUPPLIER QUALITY ENGINEER
DEPARTMENT: GLOBAL SUPPLY CHAIN QUALITY – DEPUY IRELAND
REPORTS TO: SUPPLIER QUALITY MANAGER, EU DIRECT MATERIAL
JOB LOCATION: CORK
BAND: 25
JOB PURPOSE:
The Supplier Quality Engineer is responsible for providing quality assurance leadership in the management of suppliers. Responsible for providing supplier quality engineering support and conducting assessments for activities related to supplier selection and evaluation, supplier performance, and strategic procurement.
________________________________________________________________________________
ORGANISATIONAL INTERFACES:
All Disciplines within the Manufacturing Facility, Outside suppliers and QA related equipment suppliers, and staff across DePuy Synthes Orthopaedic sites & J & J companies.
______________________________________________________________________________
MAIN DUTIES & RESPONSIBILITIES:
Conduct on-site quality and process assessments at suppliers when required to do so.
Liaising with the Manufacturing and Quality engineers in manufacturing, in assessing and addressing material quality issues.
Ensure effective and timely closure on all Supplier Corrective Action Requests.
Ensure suppliers continue to met DePuy Quality requirements with regard to Supplier Change Request process
Facilitate the completion of the quarterly Suppler Management Committee meeting
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)
• Provide support for the introduction of new components and component changes through the First Article process.
• Develop supplier capability in risk assessment such as PFMEA
Resolve problems & eliminate constraints to ensure project and supply targets are met.
Communicate and assure appropriate implementation of Quality Process Specifications (QPS), Quality Control Test Specifications (QCTS), and Raw Material Specifications (RMS) etc.
Maintain standards of housekeeping & GMP requirements.
Represent the Supply Process Quality Assurance function as required by management.
Provides guidance to Purchasing, Engineers and stakeholders in applying supplier quality system requirements.
Ensure that all Health, Safety and Environmental requirements are fulfilled.
TO ADHERE TO THE COMPANY’S PROCEDURES AS DETAILED IN THE SOP MANUAL
________________________________________________________________________________
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
Qualifications
QUALIFICATIONS & EXPERIENCE
ESSENTIAL:
• 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.
Primary Location:Europe/Middle East/Africa-Ireland-Cork-Cork
Organization: Depuy (Ireland) Limited (7386)
Job Function: Quality (Eng)