Quality and Regulatory Services Associate (2 Openings)
Duration : 6 Months
Location : Tewksbury, MA (Onsite)
Possibility for hybrid (3 days per week in office) for exceptional candidate once training period is complete. No relocation expenses will be reimbursed.
Schedule : Full-time, 40 hours expected. M-F, 8am - 5pm OR 10am - 7pm
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 liaison between customers and other Client's departments and functions.
- Responsible for supporting the projects and ongoing processes associated with Quality and Regulatory Services (QRS)
Day to Day Responsibilities :
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 guidelinesEscalate key customer and urgent inquiries to the correct department as needed on demand according to QRS guidelinesWork with customers and internal departments (Quality, Regulatory, Sales, Business Operations, Scientific Support, Customer Service) to ensure customer satisfactionProject Tasks
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 customersKey Decision Areas
Daily priorities as well as timely positive professional communications to external customers, business colleagues and teamsCriteria for Performance Evaluation
Work targets and schedules are metQRS guidelines and policies are followed, including use of email templates for customer communicationEffectively, positively & professionally interact with internal and external customersDemonstrates cooperative daily positive interactions with Customer Service, Quality and Regulatory, Supply Chain, Scientific Support, Sales and Business Operations teams regarding distributors and customers’ needs / requestsAble to appropriately determine which inquiries and issues should be escalated, and follow escalation paths as defined by QRS proceduresRequired Skills (These are skills that candidates MUST possess)
Demonstrated capacity for handling time sensitive varying customer requests and prioritizing / escalating tasks accordinglySkilled 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 industriesCourteous, articulate and professional oral and written communication skillsDesired Skills (These are skills that would be nice for candidates to possess)
Experience designing and maintaining reports and metricsKnowledgeable in use of ETQ, Sharepoint, salesforce.com and PeopleSoft.Passion for innovation, automation, and continuous improvementsMulti-lingual skills highly desiredEducation and Experience (minimum required for consideration)
HS Diploma / GED or Associate's Degree minimum requiredAt least 2-4 years of work experience in a customer facing roleDemonstrated knowledge of quality and regulatory practices strongly encouragedSoft Skills (Communication / Team / Leadership)
Ability to work under pressure while maintaining professional and positive composureAbility to apply good judgment and business acumenDesire to anticipate, meet and exceed the expectations and needs of our customersPositive attitude and outlookProven track record of positive customer interaction and teamworkAbility to handle proprietary and delicate situations appropriately, positively and professionallyCapability to effectively and professionally communicate with customers and colleagues from various regions and industriesInterview Process : First-Round 30 min Video Interview, Second-Round Onsite Panel Interview