ComplaintsQuality Support Specialist
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Job Location:
Manchester, CT - USA
Monthly Salary:
Not Disclosed
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
How you will make an impact as a Complaints/Quality Support Specialist:
- Provide general administrative support to Complaints and Quality Leadership
- Compose respond and catalog supplier emails related to complaint notification
- Ensure that complaint documentation follows Good Documentation Practices; meets QMS requirements; and complies with U.S. Food and Drug Administration (FDA) regulations / ISO requirements.
- Collaborate with cross-functional teams to support continuous improvement initiatives
- Support updating procedures and processes to support the QMS
- Support QMS collection and trending of quality data
- Support vendor qualification and management
- Ensure adherence to FDA 21 CFR Part 820 ISO 13485 and company quality management system requirements
- Assist with audit readiness CAPA follow-ups supplier files or training records as needed
- Education:
- Associates or Bachelors degree in related field (or equivalent experience)
- Experience:
- 2-5 years of experience in a regulated industry preferably in medical devices
- Familiarity with ISO 13485 FDA 21 CFR Part 820 or other quality system regulations
- Skills:
- Strong attention to detail and accuracy in documentation
- Proficient with Microsoft Office (Excel Word Outlook Teams PowerPoint)
- Excellent organizational and multitasking abilities
- Strong communication skills both written and verbal
- Ability to collaborate cross-functionally
- Ability to work independently and handle multiple tasks in a dynamic environment.
About DEKA:
One hour from the beach Boston and the mountains the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research & Development where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKAs brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering design and manufacturing. Here at DEKA some of the most innovative and life-changing products of our time are created and new ideas are always welcome and explored.
Required Experience:
Manager
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
About Company
DEKA Research and Development is perhaps best known for its founder and president Dean Kamen -- and for the Segway Personal Transporter he invented. DEKA is a design and engineering firm that develops innovative technologies, many of them in the field of medical devices. The Segway it ... View more
