Senior Global Quality Systems Engineer
Our client, a medical device company in Galway are currently looking to recruit a Senior Global Quality Systems Engineer for their site.
- The Snr. Global Quality Systems Engineer is a member of the Global Quality Systems department with primary responsibility for support of the QMS in Central America
- Their primary responsibilities are:
- Enhancement of the Quality Systems across the two Central American sites, in support of global quality system activities. Working to develop and manage quality system requirements while coordinating the implementation of these requirements across multiple sites. The individual shall possess skills in FDA (QSR) and ISO 13485 quality systems in a medical device manufacturing environment.
- The Snr Global Quality Systems Engineer may also from time to time assume other Snr Quality Engineering or Quality Management responsibilities relating to areas such as product disposition, Complaints, training - as deemed appropriate and based on experience and training.
- Develop and implement world-class Quality System processes in support of the business requirements, working closely with site Quality leaders.
- As a site matures (such as moving from component manufacturing to Finished Device manufacturing) lead the development of the site quality system to meet the additional requirements.
- Ensure all aspects of the sites QMS (Management Reviews, Internal Audits, and Supplier Management etc.) are in compliance with the global quality procedures.
- Represent Quality in customer meetings; represent the Global Quality organization and be able to outline the company Quality system and principals as part of business proposals, QBRs etc.
- Responsible for scheduling, planning, conducting, communicating and reporting on global internal audit results.
- Liaise closely with the Project Management Office to be aware of NPI/transfers into the sites that could impact the QMS, and plan for such changes.
- Support implementation of Electronic Quality Systems and other systems that could impact the QMS.
- Serves as Quality Approver on Engineering Change Orders (ECOs)/Document Change Orders (DCOs), Training Matrices, and other documents as requested.
- Facilitate improvement teams for quality systems. Provide recommendations to consolidate, standardize, simplify, and establish systems that are compliant with ISO, FDA (QSR), and customer requirements.
- Ensure applicability of current quality policies, procedures and objectives by keeping informed of the latest updates/ modifications related to relevant standards and regulations.
- Evaluate business goals, identify improvement opportunities and apply scientific methods, statistics and problem solving techniques where appropriate to improve and sustain quality system effectiveness.
- Plan and execute projects and team activities to facilitate quality system changes.
- Create and revise quality system documentation.
- Act as Lead Auditor to evaluate compliance with corporate policies, site procedures and other applicable regulatory requirements.
- Responsible for scheduling, planning, conducting, communicating and reporting on corporate internal audit results.
- Support external audits as needed, which may include assisting with prep activities, conducting mock audits, supporting front room and back room activities, and preparing responses.
- Supports change management and organizational strategy across the sites
- Lead/participate on projects which directly support compliance and/or continuous improvement of site(s), departmental and global processes.
- Develop solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors.
- Perform site trainings (GDP, GMP, CAPA, Compliance, etc.)
- Thoroughly understand the quality system process to negotiate and challenge the investigations & root-cause results, proposed actions, and effectiveness plans to ensure the true root-cause is addressed
- Maintains strong knowledge of CAPA system and procedures, drives CAPA Compliance & provides CAPA oversight.
- Adhere to company code of conduct, policies and practices.
- Demonstrate computer skills with Microsoft Office (Word, Excel, PowerPoint, and Visio).
- Calculate and present KPI metrics at internal meetings as required.
Key Competencies (Education/Skills/Experience):
- Degree in Engineering or Science.
- Post graduate qualification in Quality or at least 5 years' experience in a Quality Systems Engineering role.
- Strong compliance, process and audit experience. Proficient problem solving and investigation skills
- Manage multiple tasks and accomplish them in a timely manner
- Ability to work on own initiative with remote management.
- Trained lead auditor with experience in performing quality system audits.
- Excellent "hands-on" technical skills.
- Excellent communication and inter-personal skills.
- Highly organized with strong ability to prioritize tasks and work on own initiative.
- Ability to evaluate information gathered from observation, experience, reasoning, and/or communication, Demonstrated clarity, accuracy, precision, independent judgment and thoroughness
- Strong knowledge of ISO and FDA quality requirements.
- Excellent attention to detail and report writing skills.
- Have willingness to travel up to 20% of time.
Bimi Felix on 091730022 / firstname.lastname@example.org
Check out all our open jobs on our HERO Recruitment website - www.hero.ie
Please Note: HERO Recruitment will not forward your details to any company without your prior approval