Job Information
J&J Family of Companies Quality System Specialist in Skåne, Sweden
Quality System Specialist - 2407021014W
Description
Kenvue is currently recruiting for:
QA System Specialist
This position reports into Quality System & Performance Manager and is based at our Helsingborg site.
Who we are
At Kenvue (http://kenvue.com/careers) , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, were the house of iconic brands including OTC brands such as NICORETTE, IPREN, LIVOSTIN, IMODIUM, PEPCID and consumer health brands like NEUTROGENA, LISTERINE, NATUSAN, PIZ BUIN and o.b. . Our employees share a digital-first mindset, an approach to innovation grounded in deep human insights, and a commitment to continually earning a place for our products in consumers hearts and homes.
The Kenvue site in Helsingborg, Sweden is the home of the strong and growing brand NICORETTE, a global market leader in smoking cessation. In 2021 our production facility was recognized as a Lighthouse by World Economic Forum, marking us as a beacon in The Fourth Industrial Revolution.
The Helsingborg site is one of the largest employers in the city of Helsingborg, and the business is divided in two separate departments: Operations, where we house our manufacturing activities and R & D, our global development center for excellence working in three therapeutic areas for selfcare treatments: Smoking Cessation, Digestive Health and Cough & Cold. For more information, click here (https://www.youtube.com/watch?v=XhsbOsBiX_M)
What you will do
The QA System is responsible for reviewing quality aspects of managing the Quality System, including Document Management, Global Change Control (GCC), and Complaints. This role is pivotal in maintaining the integrity and effectiveness of our quality management system and ensuring compliance with regulatory requirements and internal standards. As a Specialist, you will ensure quality systems are effectively deployed, use statistical methods and quality tools to continuously improve process capability, participate in quality system improvement initiatives, and assist with internal and external audits:
Key Responsibilities
Document Management:
Coordinate and Maintain the electronic Document Management System, TRU.
Ensure accurate and timely processing of documents, including creation, review, approval, distribution, and archival.
Implement document control procedures to manage the lifecycle of controlled documents.
Train staff on document control processes.
Global Change Control (GCC):
Coordinate and manage the Global Change Control process, ensuring all changes are documented, reviewed, and approved according to established procedures.
Facilitate Change Control meetings, ensuring relevant stakeholders are involved.
Track and report on the status of changes to ensure timely implementation and compliance.
Assess the impact of changes on quality systems and operations.
Complaint Analysis:
Monitor trends and report findings to management, providing recommendations for quality improvements.
Ensure all complaint investigations are completed thoroughly and in a timely manner.
Develop and implement quality systems based on business, regulatory and customer requirements.
Provide training and consultation to various parts of the business
Perform periodic checks to verify appropriate application of quality systems.
Use statistical methods, quality tools and computer-generated reports to continuously improve process capability
Lead and participate in quality system improvement initiatives
Establish, maintain, and implement communications to increase awareness and promote improvement of quality issues across the business.
Provide guidance and support to processes and system tools.
Monitor and report on key metrics related to the change management process
Identify opportunities for process improvement and work with stakeholders to implement changes
Qualifications
What we are looking for
Required Qualifications
2-4 years of experience in quality assurance.
Bachelor's degree
Experience in consumer product industry or pharmaceutical/medical devices industry preferred.
Strong knowledge of software testing methodologies, tools, and processes.
Excellent problem-solving and analytical skills.
Strong communication and collaboration skills.
Ability to work independently and as part of a team.
Strong attention to detail and ability to prioritize tasks effectively.
Desired Qualifications
Analytical skills and experience analyzing syndicated data/reports.
Proficiency in the use of computer systems and applications (Microsoft Office, Windows).
Advanced skills in PowerPoint and Excel
Knowledge of quality management system standards and regulatory requirements.
Excellent communication and interpersonal skills.
Whats in it for you
Competitive Total Rewards Package
Paid Company Holidays, Paid Vacation, Volunteer Time & More!
Learning & Development Opportunities
Employee Resource Groups
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.
Primary Location Europe/Middle East/Africa-Sweden-Skne-Helsingborg
Job Function Quality Assurance
Req ID: 2407021014W