Quality Assurance Assistant

Posted Yesterday
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Roissy-en-France, Val-d'Oise, Île-de-France
Mid level
Healthtech • Other • Biotech
The Role
The Quality Assurance Assistant will perform inspections, audits, and testing of medical devices to ensure compliance with quality standards. Responsibilities include generating nonconformance reports, conducting final inspections, documenting discrepancies, operating testing equipment, and assisting Quality Engineers with data collection and project assignments.
Summary Generated by Built In

Pourquoi Merit

Notre mission est de concevoir et fabriquer des dispositifs médicaux innovants afin d’améliorer la qualité de vie des patients. Notre objectif est de recruter, intégrer et de faire grandir des équipes pluridisciplinaires afin de créer quelque chose de spécial à travers nos efforts, notre engagement et persévérance.

ESSENTIAL FUNCTIONS PERFORMED

•    Performs tasks using established and clearly defined methods.
•    Generates and distributes NC’s for specific area -- QAP’s and MPS’s.
•    Audits and inspects the production process to confirm that Device History Records are completed according to Device Master Record/QSR/GMP regulations.
•    Audits and inspects finished products to ensure that it conforms with Device History Records and applicable specification and procedures.
•    Completes final inspection paperwork.
•    Performs work order reviews for ECN's, EPWO's, NC's, etc.
•    Documents inspections and rejections on audit and inspection paperwork.
•    Segregates product when discrepancies are noted.
•    Accountable for the disposition agreement/verification of NC’s.
•    Initiates, identifies (labels) and ensures closure of NC’s.  Enters information into NC database.
•    Operates testing equipment in verifying that final product meet specification.
•    Performs dimensional audits and inspections.
•    Initiates and makes copies of final inspection paperwork.
•    Performs product transfers as applicable.
•    Tracks and maintains NC's and material testing products.
•    Submits materials for MEM/IR testing.
•    Performs specification training for production employees.
•    Quarantines product when discrepancies are noted.
•    Performs work order close-outs.
•    Trains Quality Assurance Auditors.
•    May participate in design and development activities.
•    Reviews nonconformance records (internal/external) to determine: disposition, root cause and need for corrective and preventive actions.
•    Assists Quality Engineers in performing testing and collection of related data and completing project assignments.
•    Performs other related quality audit and inspection tasks, as required.
 
SUMMARY OF MINIMUM QUALIFICATIONS

•    Education equivalent to a High School Diploma with three years work related experience, or an Associate's Degree with one year experience.
•    Excellent organizational and interpersonal skills.
•    Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs
•    Ability to work well as a team member.
•    Knowledge of various tooling and testing equipment.

COMPETENCIES

•    Test conduction
•    Test specimen preparation/equipment adjustment and operation/test data recording and analyzing
•    Engineering data extraction/processing/presentation
•    Project team participation

COMMENTS

Infectious Control Risk Category II:

The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs.  Risk category II states employment and procedures that may require exposure.

Merit Medical dans le Monde

Rejoindre Merit Medical, c’est intégrer un groupe industriel international et en pleine croissance qui compte plus de 6 400 collaborateurs dans le monde.

Fondée en 1987, Merit Medical Systems, Inc. est l'un des principaux fabricants et distributeurs de dispositifs médicaux jetables exclusifs utilisés dans les procédures interventionnelles, diagnostiques et thérapeutiques, en particulier en cardiologie, radiologie, oncologie, soins intensifs et endoscopie. Merit est au service des hôpitaux clients du monde entier avec une force de vente internationale.

Notre site de production basé à Roissy-en-France est fabriquant de dispositifs médicaux pour la radiologie interventionnelle.

Merit Medical Roissy est un site en pleine croissance et compte plus de 85 salariés qui bénéficient de nombreux avantages tels que de rémunérations compétitives, des horaires de travail flexibles ainsi que des opportunités d'apprentissage et de stage.

Culture


Un environnement de travail sain et collaboratif fait de Merit Medical un lieu de travail convivial et agréable. Nous sommes fiers de notre culture à la fois énergique et dynamique. Nous favorisons diversité et l'inclusion au sein de notre site et apprécions chaque employé en tant qu’individu.

Pour en savoir plus  www.merit.com/careers.

Top Skills

Quality Assurance
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The Company
HQ: South Jordan, UT
5,001 Employees
On-site Workplace
Year Founded: 1987

What We Do

As a global healthcare company, we understand customer needs and innovate and deliver medical solutions that transform patient care.

Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy.

Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 300 individuals. Merit employs approximately 6,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.

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