Quality Systems Engineer
|Contact Name:||Larry O’Leary|
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).
Please phone Larry on 01-2302400 / firstname.lastname@example.org / www.rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.