Highland Park, MA 01803 US
Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services while treating candidates with the professionalism and respect they deserve.
Title: Quality Specialist
Hiring Organization: Connexion Systems & Engineering
- Duration: Perm
- Pay rate: $90-120K
- Job Location: Highland Park, NJ
- Job# 14726
The person in this position will uphold and improve the product quality of medical devices manufactured and meet regulatory requirements for compliance. Apply best 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.
- Read and interpret standards in the areas of sterilization, bioburden, endotoxins, and relevant product testing for the development and modification of procedures and protocols
- Oversee supplier management program including supplier audits, methods to ensure compliance with regulatory and company requirements, supplier qualification, and supplier performance monitoring
- Own and/or support root cause determinations and execution of corrective actions per Non-Conforming Material Reports (NCMR’s) and Corrective Actions & Preventive Actions (CAPA’s)
- Facilitate environmental monitoring and ensure compliance to applicable standards and company procedures. Understands and executes risk management practices in relation to environmental monitoring and bioburden and relevant excursion
- Prepare and execute validations, technical studies, test method validations and other studies / reports as required. This includes preparation of protocols, establishment of test methodology and acceptance criteria, training personnel, execution, data analysis, investigation, and writing final reports. Analyze and report quality system data, as needed, to the Quality and Manufacturing teams
- Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes
- Utilize statistical techniques and six sigma tools to analyze processes to drive continuous improvement and/or identify performance changes.
- Bachelor’s Degree in Microbiology, Biology, Biomedical Engineer, or equivalent field from an accredited four-year college or university
- 2-6 years of equivalent experience in a related field, preferably in Medical Device
- Functional understanding of medical device standards ISO 13485, ISO 11138-7, and ISO 1497.
- Experience in using MS Word, Excel, PowerPoint and Outlook
- Strong oral and written communication skills
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