What are the responsibilities and job description for the Quality and Regulatory Associate position at Avani Tech Solutions Private Limited?
Role: Quality and Regulatory Associate
Location: Tewksbury, MA
Possibility for remote or hybrid for exceptional candidate.
Duration:6 Months
Description
Purpose of Position (i.e. projects involved with and role within group):
Ongoing Tasks
Location: Tewksbury, MA
Possibility for remote or hybrid for exceptional candidate.
Duration:6 Months
Description
Purpose of Position (i.e. projects involved with and role within group):
- Responsible for providing front-line support for internal and external customers regarding quality and regulatory-related inquiries and issues, and act as a liaison between customers and other Client departments and functions.
- Responsible for supporting the projects and ongoing processes associated with Quality and Regulatory Services (QRS)
Ongoing Tasks
- First level triage of customer complaints and QRS email queue. Sort incoming emails quickly, identify duplicates, assign to relevant functions, identifying and escalating urgent quality and regulatory issues as needed according to QRS guidelines
- Escalate key customer and urgent inquiries to the correct department as needed on demand according to QRS guidelines
- Work with customers and internal departments (Quality, Regulatory, Sales, Business Operations, Scientific Support, Customer Service) to ensure customer satisfaction
- Work with cross-functional teams including Scientific Support, Marketing/Communications, Business Operations, Sales, Quality and Regulatory, Customer Service on continuous improvement projects to delight our customers
- Daily priorities as well as timely positive professional communications to external customers, business colleagues and teams
- Work targets and schedules are met
- QRS guidelines and policies are followed, including use of email templates for customer communication
- Effectively, positively & professionally interact with internal and external customers
- Demonstrates cooperative daily positive interactions with Customer Service, Quality and Regulatory, Supply Chain, Scientific Support, Sales and Business Operations teams regarding distributors and customers’ needs / requests
- Able to appropriately determine which inquiries and issues should be escalated, and follow escalation paths as defined by QRS procedures
- Demonstrated capacity for handling time-sensitive varying customer requests and prioritizing/escalating tasks accordingly
- Skilled in all Microsoft Office applications. Ability to quickly learn and adapt to new systems.
- Customer facing, manufacturing and/or Quality/Regulatory experience in medical device and/or clinical industries
- Courteous, articulate and professional oral and written communication skills
- Experience designing and maintaining reports and metrics
- Knowledgeable in use of ETQ, SharePoint, salesforce.com and PeopleSoft.
- Passion for innovation, automation, and continuous improvements
- Multi-lingual skills highly desired
- At least 2-4 years of work experience in a customer facing role
- Demonstrated knowledge of quality and regulatory practices strongly encouraged
- Ability to work under pressure while maintaining professional and positive composure
- Ability to apply good judgment and business acumen
- Desire to anticipate, meet and exceed the expectations and needs of our customers
- Positive attitude and outlook
- Proven track record of positive customer interaction and teamwork
- Ability to handle proprietary and delicate situations appropriately, positively and professionally
- Capability to effectively and professionally communicate with customers and colleagues from various regions and industries
