Administrative Skills, Calibration, Communication Skills, Current Good Manufacturing Practice (cGMP), Data Analysis, Data Collection, Document Archiving, Documentation, Documentation Review, High School Diploma, Manufacturing, Manufacturing Audit, Manufacturing Methods, Manufacturing/Industrial Processes, Materials Testing, Medical Equipment, Medical Products, Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, Presentation/Verbal Skills, Process Manufacturing, Product Testing, Quality Control, Quality Management, Record Keeping, Regulatory Compliance, Regulatory Requirements, Test Plan/Schedule, Warehousing, Writing Skills
North Burnswick, New Jersey
The person in this position will uphold and improve the product quality of medical devices manufactured and meet regulatory requirements for compliance.Applybest practices from within the field of quality to ensure that the materials, components, processes, and manufacturing techniques are used to produce high quality and reliable products
Responsibilities:
- Responsible for the proper selection, inspection, and document review of all raw materials, in compliance with approved specifications
- Inspect items to parameters listed on drawings or quality/material specifications
- Adeptly read and/or utilizing pin gauges, rulers, micrometers, calipers, microscopes, and other inspection equipment
- Initiate nonconforming material reports or notices for items not meeting applicable specifications
- Perform manufacturing audits to ensure that manufacturing procedures are properly followed and that products are tested in accordance with approved test plans
- Maintain security and integrity of quarantined components and devices
- Execute activities associated with inspection methods, calibration, maintenance, and record keeping
- Perform data collection and limited data analysis
- Coordinate calibration activities as necessary
- Coordinate and conduct rework and inspection and testing of materials and/or finished goods, as needed, to verify that they meet specifications
- Assist with administrative functions and supports other department tasks as needed
- Perform and assist with incoming material receipt and disposition. Notifies Quality and Operations of all nonconformances
- Issue batch records and production work orders
- Review production documentation for labeling compliance on current products
- Review quality and manufacturing records for completion and accuracy
- Participate in documentation scanning / archiving processes
- Perform and assist with facility environmental control data collection and ensures conformity is achieved
- Perform periodic scheduled and unscheduled walk-through review of the manufacturing process, warehouse storage, and associated production areas to ensure that cGMPs are being followed
- Additional duties, as requested
Qualifications:
- High School Diploma, or equivalent. Associate’s degree, preferred
- Over 5 years of equivalent experience in a related field, preferably in Medical Device
- Experience in using MS Word, Excel, Power Point and Outlook
- Strong oral and written communication skills
EEO Statement:
In order to provide equal employment and advancement opportunities to all individuals, employment decisions at LeMaitre Vascular will be based on merit, qualifications, and abilities. LeMaitre Vascular does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, breastfeeding or related medical conditions, religious dress, military or veteran status or any other characteristic protected by law.
This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination, and access to benefits and training.
Applicants with disabilities may contact LeMaitre HR coordinators via telephone, fax, e-mail, and other means to request and arrange for accommodations. If you need assistance to accommodate a disability, you may request an accommodation at any time. Please contact LeMaitre HR at HR@lemaitre.com.