Search Results: 68 vacancies
...Senior Quality Engineer with ISO 13485 and FDA QSR expertise market-leading M edical Devices company in Galway. Working with a collaborative team, you will Lead Quality Engineering support of the manufacturing process & drive process continuous improvements.
RESPONSIBILITIES...
£51.3k - £64.2k per annum
...programmes in conjunction with the Validation Management.
* Conduct validation activities in compliance with US and EU regulations, ISO standards, Corporate Policies and EHS requirements.
* Support and develop direct reports to ensure their training and development needs...
County Galway
3 days ago
...for areas under their control.
Continually seeks to drive improvements in product and process quality.
Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis utilizing the quality...
...appropriate safety systems and safety architecture.
Safety control system reviews and calculations to ensure compliance to CE standards (e.g. ISO 13849).
Compilation of CE marking technical file documentation.
Ensuring equipment meets appropriate safety standards and...
...engineering projects. Attend design meetings and submit planning documentation. All work will be carried out in accordance with the company's ISO procedures.
What you'll need to succeed
You will have a Degree in Structural Engineering or relevant discipline. 2–5 years...
...Safety
To take responsibility for Health and Safety Procedures on site on behalf of the company
To ensure compliance with company ISO quality systems and procedures
To carry out Risk Assessments in accordance with above procedures
To ensure that all safety data...
...all audit schedules
Liaise with Auditor regarding year end accounts for SAS and FGP
Assist with Management Meeting Minutes and PSA/ISO Audits where necessary
Complete and Submit Bi monthly VAT returns
Credit Control
Post all deposits to the Factoring bank...
€40k - €65k per annum
...Review/analyze whether current products and processes (including actions or decisions conducted) comply with standards such as the QSRs, ISO 13485, EU MDR, etc.
Partners with R&D and other cross-functional partners to ensure the proper application of design controls, risk...
€35k - €45k per annum
...archived or disposed of.
Ensure that all quality-related documents adhere to relevant regulatory requirements, such as FDA regulations, ISO standards, and industry best practices.
Provide support for the development, implementation, and maintenance of the organization's...
...quality, customer satisfaction, and manufacturing efficiency through collaborative programs.
Ensure all project management adheres to ISO and FDA regulatory standards.
Requirements:
Bachelor’s degree in Engineering or Science, with a Master’s degree preferred.
A...
€60k - €75k per annum
...certification from an industry recognized organization is beneficial.
~ Knowledge of FDA's 21 CFR Part 820 (Quality System Regulation) and ISO 13485:2016
~ Experience in the QA activities associated with the design and development of medical devices.y.
~ Results and deadline...
...and procedures.
Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
Remains current with regulations and standards.
Support the continuous improvement of quality...
...discrepancy after cycle count
Fills out necessary maintenance and calibration records to ensure adherence to applicable standards such as (ISO 9000 ISO 14000 OHSAS 18000 ISO 22000 and KORE)
Performs duties consistent with established safety rules and procedures
Performs...
...resources in a safe environment and be responsible for Health and Safety goals.
Perform and support internal and external audits to ISO and FDA requirements.
Perform an active role in further development and continuous improvement of the Quality Management system....
€75k - €90k per annum
...the Sterilization validation (including clinical cycles) of the FASTWIRE System in compliance with current revisions of SIO 11135 and ISO 10991-7 is desirable.
Management of all Biocompatibility activities in conjunction with an approved Supplier to ensure compliance with...
...Dynamic, motivated, results-oriented approach to work.
Excellent communication, planning, and organizational skills.
Knowledge of ISO & FDA compliance.
Competencies
Values: Integrity, Accountability, Inclusion, Innovation, Teamwork
ABOUT TE CONNECTIVITY
TE...
...CCC and CMC managers to establish and ensure compliance with applicable regulations (e.g. FDA 21 CFR Part 820.198, FDA 21 CFR Part 803, ISO 13485:2003), company and department policies and procedures.
Responsibilities
Act as an effective leader in supporting quality...
...to address validation programs.
• Take technical ownership for PFMEA’s in conjunction with process engineering
• Be a leader in ISO standards within your group, be constantly aware of best industry practices.
What do we offer?
• Market-competitive total reward:...
...background with new product introduction experience preferred.
Motivated self-starter with decision-making ability.
Knowledge of ISO and FDA compliance, with emphasis on validation.
Proficiency in six sigma and lean manufacturing principles.
Excellent communication...
...ROLE REQUIREMENTS:
▪ Participant in the management and development of health and safety managements systems internally and externally [ISO 9001 & 45001].
▪ Carry out risk assessments and put enough controls in place for our clients.
▪ Drafting of health and safety...
Gaia Talent
Galway
2 days ago
