Quality Systems Specialist
il y a 3 semaines
JOB SUMMARY
Work under limited supervision to provide quality support by assisting management institutionalize compliance with global regulatory requirements. The Specialist must be capable of managing elements of the Quality Management Systems (QMS) to ensure timeliness of reports and compliance with the established standards. Providing support for audits, nonconformance investigations, or other services to this end may be required.
ESSENTIAL DUTIES
Organize and manage a Quality Survey system to provide requested feedback to customers.
Serve as the project coordinator for a given Quality System. Managing meetings involves the following responsibilities (as applicable): creating presentations, monitoring trends, analyzing data reports, ensuring timeliness on reports, writing/communicating meeting minutes, tracking action items, and presenting data to meeting attendees.
Works closely with quality management, manufacturing, engineering, regulatory affairs, and other functional groups on regulatory as well as quality system compliance issues.
Develops or participates in the development of solutions to problems of moderate to intermediate complexity. Interprets, executes, and recommends modifications to operating policies where appropriate.
Provides accurate and timely turnaround time on investigations, surveys, trend reports and other activities. Able to utilize technical writing skills to create or edit reports. Communicate effectively to management regarding those reports.
Organize and manage projects that typically will require ingenuity and evaluation as well as vendor and/or customer contact.
Fulfills FDA and international regulatory requirements relevant to each project such as GMP, IDE, PMA, 510(k), and ISO Standards.
**Perform Periodic Review of Documents**: manage or evaluate company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements and standards.
Comfortable directing or supporting internal or external audits (front room and backroom duties).
MINIMUM QUALIFICATION REQUIREMENTS
Education
Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
Experience
Minimum 4 years of experience.
Experience in a manufacturing environment preferred.
**Skills**:
Time management and flexibility.
Demonstrated ability to routinely diagnose problems and recommend solutions through teamwork, failure mode analysis, and other analytical techniques.
Knowledge of manufacturing protocols, statistical tools and methodology, and continuous improvement techniques.
Demonstrate ability to communicate effectively both verbally and in writing.
Knowledgeable in international regulations relevant to each project, i.e., GMP, IDE, PMA, 510(k), and ISO.
Work assignments may require the development of in-depth engineering or technical writing skills.
Ability to organize and manage a multitude of projects.
Or
An equivalent competency level acquired through a variation of these qualifications may be considered.
Additional Physical Requirements
May be required to travel domestically on some occasions
**Job Segment**: Technical Writer, Manufacturing Engineer, Engineer, Technology, Engineering
-
Testing and Quality Assurance Specialist
il y a 2 semaines
Brussels, Belgique Uni Systems Temps pleinAt Uni Systems, we are working towards turning digital visions into reality. We are continuously growing and we are looking for an experienced Testing and QA Specialist to will join our UniQue team! What will you be bringing to the team? - Provision of quality plans, quality assessments, quality control tests, evaluations and service level agreements...
-
Quality Assurance Lead
Il y a 2 mois
Brussels, Belgique Uni Systems Temps pleinElaboration and maintenance of information systems quality control procedures. - Create quality measurements/KPIs to track improvements in products/solutions. - Provision of quality plans and service level agreements. - Information Systems quality control and evaluation. - Provision of quality studies, quality assessments or other quality matters associated...
-
Test Automation Specialist
Il y a 2 mois
Brussels, Belgique Uni Systems Temps pleinAt Uni Systems, we are working towards turning digital visions into reality. We are continuously growing, and we are looking for a Test Automation Specialist to join our UniQue team. What will you bring to the team? - Design, prepare, and monitor automated tests. - Contribute to the development of a plan to integrate automated testing within the testing...
-
Quality Intern Audit Specialist
il y a 3 semaines
Brussels, Belgique TRS Staffing Temps plein“We are an equal opportunity employer that recognizes the value of a diverse workforce. All qualified individuals will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, disability, or any other criteria protected by governing law.” Internal Audit specialist start...
-
Power System Data Specialist
il y a 7 jours
Brussels, Belgique Apollo Solutions Temps pleinBrussels â" hybrid working (2 days per week on-site) **Salary**: â¬70-75k + benefits + bonus!  My growing Energy client is looking for a skilled Power System Data Specialist to join their growing team in Brussels on a hybrid working pattern.  **Power System Data Specialist Responsibilities**: Responsible for the product management,...
-
Quality Assurance Manager
Il y a 2 mois
Brussels, Belgique Uni Systems Temps pleinAt Uni Systems, we are working towards turning digital visions into reality. We are continuously growing and we are looking for a Quality Assurance Manager to join our UniQue team in Brussels. **What will you be bringing to the team?** - Elaboration and maintenance of IS quality control procedures. - Provision of quality plans and service level...
-
System Architect
il y a 7 jours
Brussels, Belgique M3 Systems Temps pleinM3 Systems Belgium has been created in 2004 from engineering activities in the Satellite Radio Navigation (GNSS - Global Navigation Satellite Systems) field and from consulting activities in ATM (Air Traffic Management) and Unmanned Aircraft System Traffic Management (UTM) sector. Recognized at European level thanks to strong involvement in projects from...
-
Quality Assurance Manager
il y a 1 semaine
Brussels, Belgique Uni Systems Temps pleinAt Uni Systems, we are working towards turning digital visions into reality. We are continuously growing and we are looking for a Quality Assurance Manager to join our UniQue Brussels team! What will you be bringing to the team? - Provision of quality plans and service level agreements. - Elaboration and maintenance of IS quality control procedures. - IS...
-
IT Security Specialist
il y a 4 semaines
Brussels, Belgique Uni Systems Temps pleinAt Uni Systems, we are working towards turning digital visions into reality. We are continuously growing and we are looking for a professional **IT Security Specialist to join our UniQue team in Brussels!** **What will you be bringing to the team?** - Contribute to Security Management activities: - Perform market reviews, products analyses, studies; - Lead...
-
Senior Specialist Quality Assurance
il y a 2 semaines
Brussels, Belgique Organon Temps pleinFor our Distribution & Supply Chain Quality team we are currently recruiting for the role of **Senior Specialist Quality Assurance - Supply Chain Hub 3PL Quality Oversight**. **Purpose of the role** In the role of Senior Specialist Quality Assurance - Supply Chain Hub 3PL Quality Oversight you will manage the collaboration and relation with our regional...
-
Quality Assurance Specialist/manager
il y a 6 jours
Brussels, Belgique NRB Temps plein**Who are we?** **Trasys International **is a dynamic global organization that takes pride in being the trusted partner of** EU Institutions.** With strong commitment to excellence and a **30-years track record** of delivering high-quality solutions, we are dedicated to supporting the growth and success of our clients. Our Mission is to help our clients...
-
Quality System Manager
il y a 2 semaines
Brussels, Belgique NLMK Belgium Holdings Temps plein**Company**: Is metallurgy a dusty, old-fashioned environment? Not at all! The steel industry is reinventing itself! Steel is everywhere. Join the adventure and discover modern practices and technological facilities that are well worth the diversions. The NLMK Group is one of the biggest players in the steel industry and one of the most successful in the...
-
Internal Audit Specialist
il y a 2 semaines
Brussels, Belgique Jefferson Wells Temps pleinLocation: **Brussel** - Type: **Contracting** **#20745** **Internal Audit Specialist** Vast Contract - Regio Brussel **#Audit #specialist #quality** Beschik je over een master of bachelor in een technische richting? Heb je een goede portie werkervaring met Quality Management Systems in de chemische sector? Heb je een certificaat als ISO 9001 Lead...
-
Test Automation Specialist
il y a 6 jours
Brussels, Belgique Uni Systems Temps pleinAt Uni Systems, we are working towards turning digital visions into reality. We are continuously growing and we are looking for a Test Automation Specialist to join our UniQue team. What will you be doing in this role? - Definition of test plans and test cases. - Construction of test scenarios and scripts. - Execution of tests. - Preparation and maintenance...
-
Senior Quality Systems Manager
il y a 2 semaines
Brussels, Belgique Michael Page Temps pleinAs the Successful Sr Quality System Manager - Medtech - you will have the following responsibilities:Support the International organization to ensure an adequate and effective quality management system, supports the quality policy and sustains a qualityLead and manage Quality Systems activities including audit readiness.Lead and manage specifically the...
-
Eu - Quality Assurance Manager - Brussels
il y a 2 semaines
Brussels, Belgique The White Team Temps plein**DESCRIPTION OF TASKS: - Elaboration and maintenance of IS quality control procedures. - Provision of quality plans and service level agreements. - IS Quality control and evaluation. - Provision of quality studies, quality assessments or other quality matters associated with information system projects. - Definition, elaboration, management and reporting of...
-
Eu - Quality Assurance Manager - Brussels
il y a 2 semaines
Brussels, Belgique The White Team Temps plein**DESCRIPTION OF THE TASKS**: Following tasks will be performed by external service provider: - Elaboration and maintenance of IS quality control procedures. - Provision of quality plans and service level agreements. - IS Quality control and evaluation. - Provision of quality studies, quality assessments or other quality matters associated with information...
-
Administration Support Specialist
il y a 2 semaines
Brussels, Belgique Uni Systems Temps pleinAt Uni Systems, we are working towards turning digital visions into reality. We are continuously growing and we are looking for an Administration Support Specialist to join our UniQue team. What will you be doing in this role? - Assist with the day-to-day administration of engagements and operations. - Organize, schedule and coordinate relevant meetings...
-
QA Expert Quality System
Il y a 2 mois
Brussels, Belgique Mithra Pharmaceuticals SA Temps plein**Overview**: QA Expert Quality System & Compliance **Responsibilities**: Be the QA Expert Quality System & Compliance for Mithra Pharmaceuticals SA, Novalon SA, Estetra SRL, Neuralis SA and Mithra R&D SA. Be responsible for maintaining and improving the QMS of Mithra Group. Drive and maintain an appropriate level of compliance to Mithra Group QMS. Drive...
-
Administration Support Specialist
il y a 7 jours
Brussels, Belgique Uni Systems Temps pleinAt Uni Systems, we are working towards turning digital visions into reality. We are continuously growing and we are looking for an Administration Support Specialist to join our UniQue team.What will you be doing in this role?Assist with the day-to-day administration of engagements and operations. Organize, schedule and coordinate relevant meetings with...
