Quality Assurance Manager ISO 13485 - Belgium - L
- Employer
- ClinChoice
- Location
- Belgium
- Salary
- Competitive
- Start date
- 12 Jan 2022
- Closing date
- 4 Feb 2022
View more
- Discipline
- Quality, QA / QC
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Location: Belgium
Schedule: Permanent, Full-time, Office based
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds….
TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is 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.
CROMSOURCE is an international CRO with a strong focus on quality, professional development and supportive culture. 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.
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
Main Job Tasks and Responsibilities:
- 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 5 years of experience in Quality in ISO 13485 company(ies)
Qualification as lead auditor ISO 13485 is a plus
Specific Role Requirements and Skills:
- 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 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/jobs please contact careers@cromsource.com for more information.
Who will you be working for?
About CROMSOURCE
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 Manager, Quality Assurance Manager, Quality Assurance, Quality Management System, Audit, ISO 13485, GMP, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated
Skills: Quality Assurance Manager, auditing, GMP, ISO 13485, Quality Management Location: Belgium Share:
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Company
ClinChoice is a recognized and highly respected mid-size, global, full-service contract research organization (CRO) specializing in clinical development, post-marketing, and functional service support. We provide comprehensive end-to-end solutions, taking products from early clinical development to post-approval lifecycle management. We are committed to fostering innovation in the pharmaceutical, biotechnology, medical device & diagnostics, consumer health, cosmetics, and nutraceuticals industries. Since our establishment in 1995, we have consistently delivered high-quality services and solutions throughout the entire development lifecycle of our clients’ products. We serve a wide-ranging clientele that encompasses six of the top ten pharmaceutical companies, leading medical device companies, preeminent biotechnology companies, the largest consumer health and cosmetics companies, and numerous small-to-mid-sized innovator companies. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are positioned to fulfil our clients’ needs locally and globally.
We’re on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.
- Website
- https://clinchoice.com/
- Telephone
- +44 1628 566121
- Location
-
Suite G48
268 Bath Road
Slough
Berkshire
SL1 4DX
United Kingdom
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