Our client, a medical company based in the Munster region, now seeks a
Quality Systems Engineer who will be responsible for the
implementation, co-ordination and continuous review of the CAPA,
Internal and company Corporate Compliance programs.
The successful candidate will provide focused quality engineering
support within new product development, operational, or
system/services support.
The ideal candidate will provide expertise in internal auditing
techniques and is familiar with all medical regulatory requirements
(e.g., FDA, ISO and MDD/MDR).
RESPONSIBILITIES OF QUALITY SYSTEMS ENGINEER:
Acts as an effective leader or team member in supporting quality
disciplines, decisions, and practices.
Applies sound, systematic problem-solving methodologies in
identifying, prioritizing, communicating, and resolving quality
issues.
Drives changes in procedures and standards to facilitate work
efficiency and to maintain quality.
Familiar with the internal auditing system.
Acts as a leader of quality, QSR and ISO/MDD/MDR standards within
one?s own group.
Constantly promoting awareness of best industry practices.
Making appropriate decision on a daily basis utilizing the quality
engineering manager / site QA Director as the final arbitrator on
critical quality decisions.
Develops, establishes and maintains quality engineering methodologies,
systems, and practices which meet customer, and regulatory
requirements.
Serves as a Quality representative to improve awareness, visibility,
communication on quality initiatives to support departmental,
functional, site, divisional and corporate quality goals and
priorities.
REQUIREMENTS FOR QUALITY SYSTEMS ENGINEER:
Bachelor?s Degree Level 8 qualifications, ideally with quality
discipline.
3+ years relevant work experience in Quality function within
manufacturing environment.
Proven experienced in in internal auditing.
Proven experience with all medical regulatory requirements (e.g., FDA,
ISO and MDD/MDR).
BioPharmaceutical Division specialise exclusively in the recruitment
of scientists, engineers and executives for the biotechnology,
pharmaceutical and medical device sectors.
Our client, a medical company based in the Munster region, now seeks a
Quality Systems Engineer who will be responsible for the
implementation, co-ordination and continuous review of the CAPA,
Internal and company Corporate Compliance programs.
The successful candidate will provide focused quality engineering
support within new product development, operational, or
system/services support.
The ideal candidate will provide expertise in internal auditing
techniques and is familiar with all medical regulatory requirements
(e.g., FDA, ISO and MDD/MDR).
RESPONSIBILITIES OF QUALITY SYSTEMS ENGINEER:
Acts as an effective leader or team member in supporting quality
disciplines, decisions, and practices.
Applies sound, systematic problem-solving methodologies in
identifying, prioritizing, communicating, and resolving quality
issues.
Drives changes in procedures and standards to facilitate work
efficiency and to maintain quality.
Familiar with the internal auditing system.
Acts as a leader of quality, QSR and ISO/MDD/MDR standards within
one?s own group.
Constantly promoting awareness of best industry practices.
Making appropriate decision on a daily basis utilizing the quality
engineering manager / site QA Director as the final arbitrator on
critical quality decisions.
Develops, establishes and maintains quality engineering methodologies,
systems, and practices which meet customer, and regulatory
requirements.
Serves as a Quality representative to improve awareness, visibility,
communication on quality initiatives to support departmental,
functional, site, divisional and corporate quality goals and
priorities.
REQUIREMENTS FOR QUALITY SYSTEMS ENGINEER:
Bachelor?s Degree Level 8 qualifications, ideally with quality
discipline.
3+ years relevant work experience in Quality function within
manufacturing environment.
Proven experienced in in internal auditing.
Proven experience with all medical regulatory requirements (e.g., FDA,
ISO and MDD/MDR).
BioPharmaceutical Division specialise exclusively in the recruitment
of scientists, engineers and executives for the biotechnology,
pharmaceutical and medical device sectors.
We need : English (Good)
Type: Permanent
Payment:
Category: Others
