Search Results: 38 vacancies
€55k - €60k per annum
...material commodity price trends and supply / demand situations which may impact the business.
Manage relevant change controls, deviations, CAPA's etc. to meet the requirements of the Quality management system.
Collaborate with Project managers and stakeholders to understand...
...Responsible for organizing and performing Incoming Inspection duties
Assists and performs quality investigations with supervision
Manages CAPAs with supervision
Supports the EU Clinical Trial supply process
Supports the Calibration and preventative maintenance activities....
...System (QMS) according to EN ISO13485:2016, EU MDR and 21 CFR Part 820.
Manage non-conformance and Corrective and Preventive Action (CAPA) processes, including containment, root cause analysis, and product disposition.
Drive improvements to the quality system that...
...the interface between Warehouse Inventory Control and Legal Manufacturers
Continuous improvement - Administration and support of the CAPA/ NC process through weekly continuous improvement meetings.
Escalation point for quality related non-conformances and CAPAs....
...Equipment Performance (OEE).
Oversee equipment maintenance, validation, and process development.
Resolve quality issues and support CAPAs, NCs, and audits.
Develop and manage SOPs and manufacturing standards.
Manage CAPEX for competitive advantage.
Uphold high-...
...representative role desired but not essential.
-Working knowledge of ERP, MES and PLM systems and the broader Application Ecosystem (eCERT, CAPA, GCMS, FARS, etc.), and Interfaces, combined with knowledge of key business processes.
-A proven track record of Continuous...
...compliance cross functionally in alignment with the Business Unit objective for standardization and collaboration.
Owning and completing CAPAs in Agile PLM.
Authoring and maintaining procedures, work instructions, forms, and templates to ensure that processes are compliant...
...of medical device quality systems and requirements, including measurement techniques, would be a distinct advantage.
Experience in CAPA.
Experience in root cause analytical and problem-solving skills.
Knowledge of FDA and ISO Quality systems for Medical device companies...
...Life studies through Design Verification testing.
- Investigations on product complaints and analysis of returned devices
- Support to CAPA and Non-Conformance process.
- Evaluation and scoping of process changes, material changes, vendor changes.
- Support to Labelling...
...highly regulated environment ensuring highest product quality is achieved through robust quality system processes such as GMP, NCR and CAPA etc.
Improve the production flow to achieve quality at source, rapid feedback from inspections.
Ensuring product specification requirements...
...assisting yield reporting
Investigation root cause analysis of quality issues in manufacturing and managing quality related NC’s and CAPA’s
Establish analysis techniques and other quality control tools such as SPC, Cpk, Ppk
Lead the Materials Review Board (MRB)...
...Drive Engineering solutions to ensure Right First-Time principles, driving yield improvements, Complaint reductions and supporting the CAPA process.
Continuous Improvement: Own the manufacturing process, work with key business stakeholders and operations teams to assess process...
...People: Develop and mentor engineers and technicians for succession planning.
Quality: Ensure Right First-Time principles and support CAPA process.
Continuous Improvement: Implement Lean and six-sigma tools for ongoing improvement.
Service: Deliver Exceptional...
...focused on physician needs and clinical applications.
Engage in risk management throughout the device development process.
Support CAPA and complaint investigation processes.
Requirements
~ A degree in Mechanical or Biomedical Engineering, or related field.
~2...
...operations, including leading and supporting root cause driven approaches to problem-solving efforts for quality issues.
~Manage the CAPA system and all related internal, vendor, and product-related complaints.
~Work closely with the teams in our various contract manufacturers...
...issues that arise, including customer complaints. Ensure they are effectively resolved in a timely manner using the Freudenberg Medical's CAPA system.
Ensure the Quality System is fully compliant with customer and regulatory requirements.
Lead the implementation of...
...assessments of the design to determine ability to function as intended
Responsible for timely Corrective and Preventative Actions (CAPA) change control and notification internal and vendor audits product release document control design control process and design history...
...compliance and ISO certifications for the business.
Duties and Responsibilities:
Lead complaint management and ensure completion of CAPA’s in the required timeframe
Support site investigations and CAPA management (complaint investigations and Non-conformances)...
Independent Search Solutions
Galway
3 days ago
...engineering tools and software packages (e.g., AutoCAD, SOLIDWORKS)
• Experience in writing and execution of Validation protocols, FAT, SAT, CAPA, FMEA, SOP’s, and Control Plans.
• Familiar with control procedures, such as the Change Notification and Deviation process and...
...required.
* Contribute in areas such as regulatory submissions, change control, periodic review, investigation/deviation management, CAPA’s, policy writing and Validation Master Plan’s.
* Present validation systems at internal and external audits and support quality assurance...
Team Horizon
Galway
3 days ago
