LV QA Specialist - (4779)

Under the direct supervision of a Quality Manager, the Quality Specialist assists in overseeing development, implementation, and continual improvement of quality systems, programs, and processes. This position assists in the implementation of the policies and objectives for quality and the underlying organizational processes, ensuring compliance to various standards, improvement of processes, development, and monitoring of appropriate key performance indicators. Additionally, the Quality Specialist supports internal and external audits, and assists in review, resolution and closure of corrective actions, client feedback and internal nonconformities.

The Quality Specialist is also responsible for all aspects of supplier compliance and quality including the monitoring of and reporting of supplier performance, and the issuing and resolution of supplier CAPAs. The role will provide timely feedback to suppliers regarding their performance and assist in making determinations related to vendor approval status. The Quality Specialist will assist in developing and implementing approved process changes related to Vendor Relations and may complete special projects.

About Regulated Industries

RWS Regulated Industries is a highly specialized division of RWS, a world-leading provider of technology-enabled language, content, and intellectual property services. The Regulated Industries division is focused on developing translation and content management solutions tailored to address the complex regulatory environment in force with premium sectors such as Life Sciences and Healthcare (pharmaceuticals, medical devices, CROs, healthcare companies), Finance (banks, asset management companies, insurance providers, fintech) and Legal (law firms, audit companies).

Maintain understanding of company-wide project planning, project management, and technical services procedures, and knowledge of all other Company processes.
• Assist in the design and implementation of internal systems and documented improvement projects to address them.
• Assist in the preparation of global ISO Quality Management System documents, maintenance, revisions, and version control.
• Work with department members and divisional personnel to ensure all Quality Management documents are up-to-date and reviewed periodically.
• Assist in the completion of incoming quality questionnaires for various customer compliance departments.
• Monitor client feedback and customer satisfaction survey results to identify areas for continual improvement.
• Manage the supplier feedback process and review, monitor, and analyze performance data for each supplier to determine when corrective action or additional training may be required.
• Generate reports on supplier performance, reviewing data, analyzing trends, and making determinations regarding the need to launch supplier quality investigations and vendor CAPAs
• Provide feedback to suppliers regarding their performance and collaborate with suppliers to create quality improvement or training plans.
• Administer supplier CAPAs, providing input, oversight and approval to investigation and root cause analysis, identification, and approval of CAPA Plans, confirmation of CAPA implementation and Effectiveness through review of objective evidence.
• Monitor and assist in facilitating open Corrective Action Plans for timely completion.
• Assist in the preparation of Management Review presentations while contributing to the reporting of customer and internal KPIs.
• Participate and assist in the review, root cause, and resolution of customer feedback.
• Assist in facilitating audits conducted by both internal and external parties.
• Maintain up-to-date knowledge of industry trends in life sciences translation, regulatory changes that may impact delivery of translation services as well as the competitive landscape within the localization for life sciences space.
• Actively participates in team and other meetings. Assist in implementing reporting procedures for timely and accurate reporting requirements.
• Suggest actions for the purpose of improving efficiency and product quality and providing direction for meeting the company's quality objectives.
• Assist in developing training material related to QMS controlled documentation.
• Assist in developing and supporting department/team goals and objectives.

Additional Duties

• Performs other related duties, as assigned, for the purpose of ensuring the efficient and effective completion and shipment of projects.

Note: The above description is illustrative of tasks and responsibilities. It is not meant to be all inclusive of every task or responsibility. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Bachelor's Degree or equivalent work experience in Business, English, Foreign Language, Linguistics, Social or Applied Science, or another related field.
• Translation, Localization Project Management, Localization Operations Management, or Localization Quality systems experience minimum two years.
• Demonstrated successful quality systems or related administration experience minimum three years.
• Organizational and time management skills; ability to prioritize.
• Knowledge of English grammar, syntax, and word usage and excellent writing skills
• Fluent communication skills of written and verbal English.
• Ability to communicate effectively, both orally and in writing.
• Ability to carry out instructions furnished in written or oral form, and to work without supervision.
• Ability to understand, apply and use personal computers and software applications (e.g., Word, Excel, PowerPoint, Outlook, Adobe Acrobat, Teams).
• Ability to analyze and problem solve job-related issues.
• Ability to work with a diverse group of individuals across different levels of the company.
• Ability to maintain confidentiality of information regarding company financial and other information.
• Ability to establish and maintain cooperative working relationships with others contacted in the course of work.
• Ability to provide guidance for employees and provide clear direction in a respectful manner.
• Teamwork and consensus-building skills.
• Ability to resolve customer service issues in a professional and efficient manner.

At RWS, we're here for one purpose: unlocking global understanding.

As a unique, world-leading provider of technology-enabled language, content, and intellectual property services, we remove the barriers to communication to make global connection possible. Our unrivalled experience and deep understanding of language have been developed over more than 60 years. As we look to shape the future, our ambition is to create a world where understanding is universal for everyone.

We work with over 80% of the world's top 100 brands, more than three-quarters of Fortune's 20 'Most Admired Companies' and almost all the top pharmaceutical companies, investment banks, law firms and patent filers. Our client base spans Europe, Asia Pacific and North and South America. Our 65 global locations across five continents service clients in the automotive, chemical, financial, legal, medical, pharmaceutical, technology and telecommunications sectors.

If you like the idea of working with smart people who are passionate about breaking down language barriers and giving back to their communities, then you'll love life at RWS. Our work fundamentally recognizes the value of every language and culture. So, we celebrate difference, we are inclusive and believe that diversity makes us strong.

We want every employee to grow as an individual and excel in their career. In return, we expect all our people to live by the values that unite us: to partner with colleagues and clients, to adopt a pioneering spirit, to be positive in progressing the work we do, and always to deliver what we promise.

RWS Values

Get the 3Ps right - Partner, Pioneer, Progress - and well Deliver together as One RWS.

For further information, please visit: RWS

RWS embraces DEI and promotes equal opportunity, we are an Equal Opportunity Employer and prohibit discrimination and harassment of any kind. RWS is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at RWS are based on business needs, job requirements and individual qualifications, without regard to race, religion, nationality, ethnicity, sex, age, disability, or sexual orientation. RWS will not tolerate discrimination based on any of these characteristics

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