QA Manufacturing Support Engineer-1421549W
Description
JOB TITLE: QA MANUFACTURING SUPPORT ENGINEER
DEPARTMENT: VALUE STREAM/QUALITY
REPORTS TO: QA COMPLIANCE TEAM LEADER
JOB PURPOSE:
To provide Quality Engineering and Process Excellence support in a defined Business Unit / Value Stream environment for In-Process, Finished Product, First Articles & New Product Introduction.
_____________________________________________________________________
ORGANISATIONAL INTERFACES:
All Disciplines within the Manufacturing Facility, Outside suppliers and QA related equipment suppliers, Staff from other DePuy & J & J companies.
_____________________________________________________________________
MAIN DUTIES & RESPONSIBILITIES:
• Actively support all Compliance Initiatives with the Value Stream and Plant
• Actively support all defined Value Stream and Plant goals and objectives.
• Work as an integral member of authorised Value Stream Process Excellence initiatives
• Identify projects to resolve scrap, reprocessing and special causes that have a negative impact on Value Stream and Plant Goals and Objectives.
• Compile Quality Process Specifications for new/transferred products/processes
• Validate new/changed production processes/systems with Business Unit personnel
• Design and validate Quality System processes where appropriate (CSV and Inspection Process)
• Reviews product designs, test protocols and co-develop critical characteristics/tolerances for initial testing and validations and subsequent routine manufacturing controls.
• Conduct internal Quality System Audits as necessary
• Participates in design evaluations where appropriate
• Participates in process evaluations (e.g. FMEAs).
• Devises and implements methods and procedure for inspecting, testing and evaluating plans for subsequent routine production.
• Support Quality System activities within manufacturing cells such as Internal Audits, complaint investigations, close call and corrective action investigations.
• Perform/document dimensional/visual inspections and non conformance and deviations as required
• Manage a variable workload to meet operational requirements.
• Ensure that all Health, Safety and Environmental requirements are fulfilled.
PRINCIPLE ACCOUNTABILITIES:
• Process Excellence – Continuous Process Improvement
• Process/Quality Input for validation processes and new product introduction
• Inspection of products & processes
• GMP
TO ADHERE TO THE COMPANY’S PROCEDURES AS DETAILED IN THE CSOP’s on AGILE
KEY COMPETENCIES REQUIRED:
• High Attention to Detail
• Pro-active approach to Work
• High Standards
• Flexible
• Excellent Communication Skills
• Analytical Skills
• Team Player
• High level of Numeracy
• Highly Computer Literate
• Planner & Organiser
• Active Listener
• Continuous Improvement Focus
Qualifications
QUALIFICATIONS & EXPERIENCE
ESSENTIAL:
• Engineering degree Quality / Manufacturing / Engineering and/or
• Minimum 2 - 3 years experience in Quality Assurance/Engineering
• Proven track record in Compliance & Continuous improvement projects
• Basic PC Skills.
• Ability to interpret engineering drawings/specifications.
• Familiarity in areas of various Inspection Techniques.
DESIRABLE:
• Process Excellence Green Belt/Black Belt
• Working knowledge of Quality Systems (FDA/ISO) within a
regulated environment.
THIS JOB DESCRIPTION IS NOT AN EXHAUSTIVE LIST OF THE JOB HOLDERS RESPONSIBILITIES.
Primary Location:Europe/Middle East/Africa-Ireland-Cork-Cork
Organization: Depuy (Ireland) Limited (7386)
Job Function: Quality (Eng)
Description
JOB TITLE: QA MANUFACTURING SUPPORT ENGINEER
DEPARTMENT: VALUE STREAM/QUALITY
REPORTS TO: QA COMPLIANCE TEAM LEADER
JOB PURPOSE:
To provide Quality Engineering and Process Excellence support in a defined Business Unit / Value Stream environment for In-Process, Finished Product, First Articles & New Product Introduction.
_____________________________________________________________________
ORGANISATIONAL INTERFACES:
All Disciplines within the Manufacturing Facility, Outside suppliers and QA related equipment suppliers, Staff from other DePuy & J & J companies.
_____________________________________________________________________
MAIN DUTIES & RESPONSIBILITIES:
• Actively support all Compliance Initiatives with the Value Stream and Plant
• Actively support all defined Value Stream and Plant goals and objectives.
• Work as an integral member of authorised Value Stream Process Excellence initiatives
• Identify projects to resolve scrap, reprocessing and special causes that have a negative impact on Value Stream and Plant Goals and Objectives.
• Compile Quality Process Specifications for new/transferred products/processes
• Validate new/changed production processes/systems with Business Unit personnel
• Design and validate Quality System processes where appropriate (CSV and Inspection Process)
• Reviews product designs, test protocols and co-develop critical characteristics/tolerances for initial testing and validations and subsequent routine manufacturing controls.
• Conduct internal Quality System Audits as necessary
• Participates in design evaluations where appropriate
• Participates in process evaluations (e.g. FMEAs).
• Devises and implements methods and procedure for inspecting, testing and evaluating plans for subsequent routine production.
• Support Quality System activities within manufacturing cells such as Internal Audits, complaint investigations, close call and corrective action investigations.
• Perform/document dimensional/visual inspections and non conformance and deviations as required
• Manage a variable workload to meet operational requirements.
• Ensure that all Health, Safety and Environmental requirements are fulfilled.
PRINCIPLE ACCOUNTABILITIES:
• Process Excellence – Continuous Process Improvement
• Process/Quality Input for validation processes and new product introduction
• Inspection of products & processes
• GMP
TO ADHERE TO THE COMPANY’S PROCEDURES AS DETAILED IN THE CSOP’s on AGILE
KEY COMPETENCIES REQUIRED:
• High Attention to Detail
• Pro-active approach to Work
• High Standards
• Flexible
• Excellent Communication Skills
• Analytical Skills
• Team Player
• High level of Numeracy
• Highly Computer Literate
• Planner & Organiser
• Active Listener
• Continuous Improvement Focus
Qualifications
QUALIFICATIONS & EXPERIENCE
ESSENTIAL:
• Engineering degree Quality / Manufacturing / Engineering and/or
• Minimum 2 - 3 years experience in Quality Assurance/Engineering
• Proven track record in Compliance & Continuous improvement projects
• Basic PC Skills.
• Ability to interpret engineering drawings/specifications.
• Familiarity in areas of various Inspection Techniques.
DESIRABLE:
• Process Excellence Green Belt/Black Belt
• Working knowledge of Quality Systems (FDA/ISO) within a
regulated environment.
THIS JOB DESCRIPTION IS NOT AN EXHAUSTIVE LIST OF THE JOB HOLDERS RESPONSIBILITIES.
Primary Location:Europe/Middle East/Africa-Ireland-Cork-Cork
Organization: Depuy (Ireland) Limited (7386)
Job Function: Quality (Eng)