...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...
Hobson Prior International Ltd
Connacht
3 days ago
...CRDN functions on design control related initiatives.
Collaborate across OUs on shared process and procedures.
Participate in CAPAs affecting the PDP or associated processes.
Provide PDP and Design Control training to CRDN program teams and provide expertise...
Medtronic GmbH
Connacht
2 days ago
...progression opportunities to develop a career in Quality Assurance.
Key Responsibilities:
* You will assist and manage the closure of existing CAPAs and ensure robust actions are in place.
* Maintain strong relationships with managers and colleagues within the technical and QA...
County Mayo
1 day ago
...regarding construction projects and engineering operations at the site.
* Ensuring effective root cause analysis and implementation of CAPAs for any EHS incidents, injuries or near misses.
* Providing your Input to EHS Goal Setting, EHS Senior Management Reviews and...
County Mayo
21 days ago
£51.4k - £64.3k per annum
...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...
County Galway
20 days ago
...assigned and lead quality improvements in conjunction with Quality Manager
Complete Internal audits per the audit schedule
Support CAPA system
Essential Functions of the Role
People Management
Problem Solving and Analyzing
Attention to detail
Change...
...overall Product Flow function within the Core 1 Business Unit. In this role, you will be actively involved and manage the batch related CAPA’s as they arise in the business unit taking them from the initial review state through RCA, approval, batch disposition and delivery of...
€40k - €45k per annum
...Support QA programs to ensure regulatory compliance.
Ensure effective closure of Quality System documents (Audit Actions, NCRs, CAPAs, etc.).
Collaborate with the team leader on strategic goals and objectives.
Maintain and develop risk management lifecycle.
Drive...
...coordinator in investigation, root cause analysis, disposition, and corrective action of non-conformances & customer complaints
Perform CAPA reports
Support clients in product submission to applicable regulatory authorities
Support Quality Department in implementing and...
...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...
...Metrics, creation of Dashboard for monthly reporting, set meaningful and relevant targets
Thorough incident investigation and delivery of CAPA’s on time.
Support site in product, process and equipment validation where required.
Implement Maintenance Excellence Programme,...
...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....
...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-...
..., environmental and quality related SOPs.
Ensure successfully review, amendment and implementation of changes to SOPs and managing CAPAs.
Promote a culture of perfect performance and Enhanced Right first time within their team.
Liaise with the relevant departments...
...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....
...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...
...and Antibiotic Assay.
Report writing.
Draft and review documentation –SOPs, protocols, training modules, investigations, reports, CAPAs and deviations.
Trending of results and preform investigations into adverse or out of limit results
Validation of equipment and...
...strategy, new product introduction, and manufacturing issue resolution.
Manage assigned QMS areas , including Deviation, Change Control, CAPA, audits, complaints, vendor management, and approval of batch records and production materials.
Generate, review, and approve SOPs/...
...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...
...Quality review of SOP'S.
~Review and approve of product change controls.
~Advise on quality related issues with clients.
~Perform CAPA reports.
~Conduct internal audits.
Experience/Requirements
~Minimum level 8 degree in Science or Engineering discipline.
~3-...
...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...
...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)...
...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...
Pale Blue Dot Recruitment
Connacht
4 days ago
...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...
...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...
...corrective actions to prevent re-occurrence for customer and internal issues.
Oversee non-conforming material, customer complaints, CAPA investigations, analysis, and improvement.
Utilize data analysis and trending, statistical process control, root cause analysis and...
...communication. Especially in the area of New Products but also existing products, participation in areas such as Customer Complaints, CAPA’s, etc., either as responsible for timely closure or providing technical support.
Completing any tasks within the project scope including...
...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...
...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
5 days ago