Campus Pride Jobs

[Defibtech is seeking a Quality Support Specialist responsible for providing essential support to quality activities such as entering, analyzing, assigning investigations, and processing quality complaints within the Quality Management System. In addition, the Quality Support Specialist will also be responsible for supporting and aiding with the recognition of adverse event information and the reporting of that information to regulatory agencies. This position is based onsite at our Branford, CT manufacturing site.

[Core Responsibilities: ]{arial",sans-serif"=""}]{arial",sans-serif"=""}

• Documents records of complaint investigations in applicable systems and formats using established guidelines.
• Reviews and evaluates complaints against established criteria and/or guidelines to determine investigation activities and applicable reporting requirements.
• Organizes complaint reports for review and submission in a timely and efficient manner.
• Maintains and/or updates quality metrics, including metrics related to complaints.
• Supports other quality activities as needed and requested.
• Demonstrates Defibtech s values on the job and promotes and participates in continuous improvement.
• Actively supports compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including but not limited to FDA, Quality Systems Regulations, safety regulations and applicable statutes).

[Qualifications / Requirements: ]{arial",sans-serif"=""}

• High school diploma or equivalent with 2 or more years of related work experience.
• A minimum of 2 years of previous work experience in the medical device industry is required.
• Preferred candidates will have 5 or more years of previous experience supporting quality. Previous experience in complaint handling is highly preferred.
• Preferred candidates will have experience with CRM systems, such as Salesforce, and eQMS systems such as Arena or similar.
• Proficient with Microsoft Office Suite or related software.
• Detail oriented with strong analytical and problem-solving skills.
• Strong reading comprehension skills and ability to assess written information.
• Strong written communication skills and ability to clearly convey information with an appropriate amount of detail.
• Excellent organizational skills and the ability to manage responsibilities in a fast-paced environment.

[Work Environment and Physical Demands: ]{arial",sans-serif"=""}

• Office setting with ongoing computer-based work. Onsite preferred.
• Sedentary work that primarily involves sitting, occasional standing and walking.

[Compensation and Benefits: []{times=""}]{arial",sans-serif"=""}