Senior Specialist QA

2 months ago


Cork, Ireland Stryker UK Limited Full time
Work Flexibility: Hybrid

QA Senior Specialist, UK & BNN

Group: RAQA

Division: EMEA

Location: UK/Nordic/Benelux

Position Summary

Develops and applies sound knowledge and understanding of the QA frameworks, legislative requirements, processes and procedures in the EMEA distribution organisation. Responsible for developing and maintaining the QMS and ensuring compliance to the ISO9001 standard

Key Activities & Accountabilities

Along with the QA Manager and QA team, responsible for ensuring compliance with the ISO 9001 standard across UK&BNN sites. Develop and maintain UK&BNN QMS and documentation system to ensure sites operate within approved Corporate and Regional EMEA process and procedures. Ensure quality records are established and maintained to provide evidence that the QMS is being followed and that there is a system in place for the identification, storage, protection, retrieval, retention time and disposition of such records. Support annual Management Reviews of the Quality System to ensure and monitor its suitability, adequacy and effectiveness. Support a program of Internal Quality Audits covering all processes. Support continual improvements of the QMS, ensuring that evidence of corrective and preventive actions taken are recorded and reviewed. Work with process owners to ensure timely CAPA investigation and closure. Assist in creation of a QMS training program. Ensure that all new staff are inducted into the requirements of the QMS related to their own roles and responsibilities. Provide update training as necessary. Analyse data on the effectiveness of the QMS and evaluate where continual improvements of the QMS can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources Support departmental process owners to identify, implement and document improvement opportunities. Assist in creation of quality objectives for RAQA and non-RAQA departments Report to management on the performance of the QMS and any need for improvement.

Education

BSc degree in relevant field. Advanced Degree preferred. 

Experience

2-4 years relevant experience

Knowledge/Competencies

Project support and time management skills, writing, coordination, and execution of more complex QA items. Demonstrated knowledge and application of quality requirements including ISO 9001 Knowledge of environmental quality standard ISO 14001 an advantage Some technical knowledge of medical device quality requirements Ability to develop influence across the organization Coordinate and support technical and scientific QA activities. Ability to act under minimal supervision and take decision in the relevant area of competence Clearly conveys information to peers, supervisors, and other stakeholders across the EMEA organisation, Design Divisions and third-party distributors. Attend meetings with regulatory agencies, internal and external audits and other stakeholders. Prepares briefings and other information documents. Seeks out diverse ideas, opinions, and insights, and applies them in the workplace. Connects and relates well with people who think and act differently than oneself. Embraces scrutiny and accepts feedback as opportunity to learn and improve. Preparation of QA metrics for reporting purposes. High attention to detail and process consciousness. Strong IT skills, including Microsoft Office. Fluent in English (+ local language where applicable).

#IJ

Travel Percentage: 20%

  • Cork, Ireland Catalyx Full time

    Catalyx is seeking a QA Specialist to join our team and work on our customer site in Cork. The QA Specialist is responsible for the creation, revision, and delivery of GMP documentation to our FDA-regulated customers. Who We Are: Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company...


  • Cork, Ireland Reperio Human Capital Full time

    Senior QA Automation Engineer - 60k - 65kCork, Ireland - HybridAs a Senior QA Automation Engineer, you will be reporting to the Product Manager and working with the Automation Team. You will help by supporting them as they write integration, end-to-end and unit testing. You would be responsible for producing testing frameworks for new projects and developing...

  • QA Specialist

    6 months ago


    Cork, Ireland Westbourne IT Global Services Full time

    Essential Duties and Job Functions: ·Participates within inter-departmental and cross-functional teams ·Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements Reviews routine release documentation for Packaging Components & Starting Materials Reviews Supplier investigations, Temptales and disposal of...


  • Cork, Ireland Forcepoint Full time

    Who is Forcepoint? Forcepoint simplifies security for global businesses and governments. Forcepoint’s all-in-one, truly cloud-native platform makes it easy to adopt Zero Trust and prevent the theft or loss of sensitive data and intellectual property no matter where people are working. 20+ years in business. 2.7k employees. 150 countries. 11k+...


  • Cork, Ireland BioMarin Full time

    Who We Are For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled...


  • Cork, Ireland BioMarin Full time

    Who We Are For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled...


  • Cork, Ireland RT Lane Ltd Recruitment Full time

    R.T. Lane Recruitment are currently recruiting for a QA Specialist Quality Systems to work with a Pharmaceutical Company in Cork. This is an 11-month contract with strong potential for extension. **Please note that candidates must hold the correct working visa for Ireland as my client cannot offer visa assistance and must be already residing in Ireland** **...


  • Cork, Ireland Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 employees around the world work to discover and bring life-changing...

  • QA Specialist

    7 months ago


    Cork, Ireland Westbourne IT Global Services Full time

    Main Purpose and Objectives of Position: ·Provide Quality leadership, direction and governance for the specific area of responsibility. ·Manage quality-related matters specific to area of responsibility ·Responsible for approving appropriate quality-related documents. Approval signature confirms that company and GMP requirements have been met. ...


  • Cork, Ireland Proofpoint Full time

    It's fun to work in a company where people truly BELIEVE in what they're doing! We're committed to bringing passion and customer focus to the business. Corporate Overview Proofpoint is a leading cybersecurity company protecting organizations’ greatest assets and biggest risks: vulnerabilities in people. With an integrated suite of cloud-based...

  • AML QA Specialist

    6 months ago


    Cork, Ireland Amazon Ireland Support Services Limited - A94 Full time

    The AML Programme team in Registration and Compliance (R&C, part of Selling Partner Risk) is looking for a Portuguese-speaking quality control specialist to join a team of quality specialists covering the Know Your Customers programme. The role is critical to ensure that Amazon’s payments businesses expand with appropriate controls and quality processes in...


  • Cork, Ireland Stryker Ireland, Ltd. Full time

    Work Flexibility: Onsite Senior Technician, Quality Reports To: Associate Manager/Manager, Quality Assurance Contract: 12 Month Contract Location: Springhill, Carrigtwohill Shift: Evening Shift. 3.00 pm - 11.00 pm (Some Flexibility). Key Areas of Responsibility To provide expert QA support to Operations, ensuring operational goals...


  • Cork, Ireland Reperio Human Capital Full time

    IT Support Specialist Contract | €260-€280/day | Cork | HybridA client of mine is looking for an experienced IT Support Specialist to join their team in Cork. This role focuses on delivering exceptional Level 2 and Level 3 support while contributing to system optimization and key IT initiatives.Responsibilities: Provide Level 2 and Level 3 support across...


  • Cork, Ireland Endo Operations Limited Full time

    Description The Senior Quality Specialist, Quality Operations has responsibility for overseeing quality in Contract Manufacturing Quality Operations and Quality Management Systems (all aspects), as well as handling Corrective and Preventive Actions (CAPA). May manage projects or serve as a designee to the Subject Matter Expert (SME) or Process Owner...


  • Cork, Ireland Amazon TA Full time

    The Compliance Quality team in Registration and Compliance (R&C, part of Selling Partner Risk) is looking for a German-speaking quality control specialist to join a team of quality specialists covering the Denver Audit the Auditor programme. The role is critical to ensure that Amazon’s payments businesses expand with appropriate controls and quality...


  • Cork, Ireland Westbourne IT Global Services Full time

    This experienced position requires requiring sound knowledge of quality assurance systems, methods and procedures. The candidate will lead product complaint investigations including coordinating the different investigation elements with site departments, completing detailed review of complaint samples against master files to determine authenticity,...


  • Cork, Ireland Dornan Full time

    Role and Responsibilities: Supports Project Engineering teams and oversees electrical engineering development  Working directly with clients and project teams to define project requirements and develop technical solutions and support project commercials  Develop and agree design processes and design deliverables  Lead Pre-Construction...


  • Cork, Ireland Marymount University Hospital & Hospice Full time

    GradeClinical Nurse Specialist/Candidate (General)The RoleThe Clinical Nurse Specialist will undertake a diverse range of responsibilities within the community palliative care team, offering specialised nursing advice, expertise, and support. Working closely with the Primary Care Team in the Community and the Hospital team, they will contribute to the...


  • Cork, Ireland Recruitment by Aphex Group Full time

    Purpose The role requires the individual to perform a series of tasks to guarantee the quality of our products and processes, and adherence to the Quality Management system. The responsible person will contribute to the organisation of quality control and process validation activities as well as interacting with various stakeholders in the business. This is...


  • Cork, Ireland Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. Eli Lilly Cork, is made up of a talented diverse team of over 1,400 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical...