Quality Systems Specialist
Location
Providence, RI | United States
Job description
Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, Veranex clients realize efficiencies in cost and time, while our comprehensive solutions unify the entire development process. Veranex partners with the world's most influential life science and medical device companies to research, design, develop and commercialize new healthcare technologies and treatments to advance patient care.
About This Role:
Veranex has an exciting opportunity to join our team as a Quality Systems Specialist. You will be part of a team working to improve lives globally through medical technology innovation. The Quality Systems Specialist will provide company leadership in the maintenance and improvement of corporate-wide quality management systems and support processes. They will proactively manage the various elements of the quality system to ensure compliance to applicable national and international quality system regulations. This position also performs cleanroom monitoring, maintains QSR/ISO 13485 Quality Systems compliance, executes Preventive Maintenance, and equipment control processes. This position reports to the Head of Quality Systems.
What You Will Do:
- Support the Quality Systems Department by providing hands-on ownership for the various elements of the Veranex Quality Management System including corrective and preventive action (CAPA), and/or internal audits etc.
- Strong investigational and communication skills, with a strong skillset to document investigations, perform root cause analysis, and determine corrective action plans
- Ensure timely closure of Audit Findings and Continual Improvement Items.
- Ability to support monthly operations meetings by compiling and presenting metrics.
- Support Quality Systems activities such as ownership of CAPA’s, customer complaints, audit finding, etc., as directed by the Head of Quality Systems.
- Compile and track appropriate metrics and data to demonstrate Quality Management System Compliance, as directed by the Head of Quality Systems.
- Ownership of CAPAs, customer complaints, audit findings, and/or internal audits.
- Experience with performing GAP analysis (i.e. translating regulations into Veranex SOPs)
- Review and approve Internal and External audit reports, as well as any audit findings.
- Perform Risk Assessments for quality observations.
- Ability to perform Quality System Software Validations, as needed.
- Other responsibilities as signed by direct supervisor.
Qualifications
Required skills:
- Bachelors’ Degree or higher in an Engineering discipline or equivalent experience.
- Minimum of 3 year’s relevant experience in Quality Systems and Quality Control in a new product development environment for medical devices.
- Must have good written & oral communication skills and the ability to communicate appropriately with different engineering teams, Project Management, clients, and customers
- Investigational and communication skills
- Strong attention to detail
- Flexibility to multi-task and perform a wide range of activities
- Excellent computer skills, including MS Office proficiency and document control software
- Medical device GMPs, ISO 13485, MDD 93/42, Technical files, and QSR requirements for documentation
Preferred:
- Demonstrated working knowledge of Quality Management Systems requirements as it relates to ISO 13485 and FDA 21 CFR 820
- Working knowledge of MasterControl Quality Management Software
- Audit Support (internal or external)
Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.
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