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Quality Engineer

Hybrid - Piscataway, NJ

About Spectrum Vascular 

Spectrum Vascular is an innovative medical device company focused on vascular access and medication management. Our mission is to improve the lives of patients worldwide by providing caregivers with high quality, innovative products with exceptional customer service. We are a 
company that was formed through the acquisition of a portfolio of trusted products that have been widely used by customers for decades. Innovation has been a core strategic pillar throughout our history and many of our products have been designed to deliver antimicrobial and antithrombogenic protection or to support certain patient populations such as those who are critically ill and pediatrics. This role represents a unique opportunity to join a dynamic and 
growing team with established products and an entrepreneurial mindset. 

Role Description: 

The Quality Engineer is responsible for providing hands-on support to assure the successful transfer of acquired technology to a contract manufacturing partner on schedule. This position will monitor, maintain, and/or improve the quality and performance of the Spectrum Vascular catheter product portfolio through technical evaluations, maintenance of design history files, and quality support to address user and/or business needs. 

Key Responsibilities: 

  • Execute activities necessary to support the vascular access business, specifically the PICC and Mid-line catheter portfolio.
  • Monitors, maintains, and/or improves the quality and performance of the portfolio through technical evaluations, design history file maintenance, and design improvement implementation to address user and/or business needs.
  • Perform technical evaluations related to supplier and manufacturing changes to existing products.
  • Perform design change assessments to determine impact of changes to commercial products.
  • Support new indications, regulations, and marketed regions associated with existing commercial products.
  • Maintain Risk Management Files for existing products based on post market surveillance.
  • Interfaces with external suppliers and internal project teams to ensure the quality of Spectrum Vascular products.
  • Review test protocols and reports to support development and transfer of projects.
  • Ensure all activities are executed in alignment with design controls, with the proper documentation for traceability. Support Regulatory filing activities (per 21 CFR 820.30, 21 CFR part 4, ISO 13485), and work closely with team to establish and maintain design control procedures.
  • Partner with functional areas to develop appropriate prioritization plans and appropriately escalate changes in resource demand, risks, gaps, or challenges.
  • Facilitate decision-making, collaboration, and problem-solving with people at all levels of the organization to accomplish shared program.
  • Effectively manage multiple projects and responsibilities.

Role Requirements: 

  • Bachelor’s degree in mechanical or biomedical engineering preferred.
  • Three years-plus of relevant medical device industry experience in quality engineering and/or manufacturing operations.
  • Knowledge and understanding of molding and extrusion operations, as well as assembly, labeling, and packaging.
  • Good understanding of FDA regulations, QMS, GMP and ISO standards.
  • Experience managing diverse project activities with contract CMO facilities, and in particular managing and communicating quality requirements between vendors.
  • Strong computer skills including proficiency in Excel, Word, SolidWorks, eQMS, and statistical methods.
  • Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results.
  • Natural entrepreneurial spirit with unrelenting dedication to delivering results.
  • Desire to work in a fast-paced, innovative environment.
  • Natural collaborator who enjoys working on a cross-functional team.

Work Environment: 

  • Remote-based
  • Dynamic, interactive, fast-paced, and entrepreneurial environment
  • Travel – up to 35%, additional may be required during execution of validation activities

  

Spectrum Vascular is an Equal Opportunity Employer and committed to creating a diverse and inclusive company culture. Spectrum Vascular does not discriminate against candidates and employees because of their disability, sex, race, gender identity, sexual orientation, religion, 
national origin, age, veteran status, or any other protected status under the law. 

  

  

 

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