Schedule: Permanent - Full Time - Office based
TalentSource Life Sciences is currently searching for a Quality Assurance Manager to join one of our partner companies, in Walloon Brabant. Our client develops, manufactures and supports innovative equipment and software solutions for diagnostic, cancer treatment, and industrial applications.
As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.
TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your TalentSource Line Manager.
Scope of the role:
The Quality Assurance Manager is responsible for creating and supporting a Quality culture across the company by driving compliance activities through product life cycle. This includes driving the Quality and Compliance activities for the Quality Management System (QMS) implementation, audits, complaints, CAPA, continuous improvement.
- Support management and maintenance of the Quality Management System. Ensure it is in place and it is recognized, understood and maintained across the company
- Communicate internally on the Quality Management System implementation and review progress
- Lead quality to ensure continuous improvement and compliance of the Quality Management System
- Ensure that GMP/Quality Standards/Procedure/Methods/Guidelines are applied
- Lead quality efforts in corporate development of analytical methods
- Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implication regarding these changes
- Provide quality guidance to process improvement projects and programs
- Support efforts to reach GDPR compliance
Education and Experience:
- University Degree
- A minimum of 10 years of experience in Quality in ISO 13485 company(ies)
- Qualification as lead auditor ISO 13485 is a plus
- High level computer literacy; including MS Office, SharePoint, Flowcharting software, Acrobat, etc
- Excellent level of oral & written communication skills enabling to act as a facilitator and/or educator with strong leadership skills
- Adaptable and willing to take on multiple new tasks and responsibilities
- Independent collaborative self-starter with the ability to make appropriate quality-related decisions in real time
- Process orientated, Logical, analytical, meticulous, highly organized and able to analyze data & implement solutions
- Proficient English
Our benefits when working in Belgium:
- Competitive Salary
- Group and hospitalisation insurance
- Electronic meal vouchers
- Internet reimbursement
- Company Car with fuel card depending on the function
- Dedicated Line Manager
- Regular face-to-face or phone meetings with line manager
- Full annual performance review process
- Ad-hoc team events and end of year party
- Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
- Employee satisfaction survey - your feedback is important for continuous improvement
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002574
or please contact Vaia.Hixson@cromsource.com for more information.
Who will you be working for?
CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.
Our Company Ethos
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.
About TalentSource Life Sciences
TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.
CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
Key words: Quality Assurance Manager, Quality Assurance, Quality Management System, Audit, ISO 13485, GMP
Quality Assurance Manager, Quality Manager, auditing, GMP, ISO 13485, Quality Assurance