Quality and Regulatory Services Associate (2 Openings)

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

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https : / / divihn.com / find-a-job /

to learn more and view our open positions.

Please apply or call one of us to learn more

For further inquiries regarding the following opportunity, please contact our Talent Specialist :

Balaji at

(630) 847-1776

Title : 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.

Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.

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 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

Project 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 customers

Key Decision Areas

Daily priorities as well as timely positive professional communications to external customers, business colleagues and teams

Criteria for Performance Evaluation

Work targets and schedules are met

QRS guidelines and policies are followed, including use of email templates for customer communication

Effectively, positively and 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

Required Skills (These are skills that candidates MUST possess)

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

Desired Skills (These are skills that would be nice for candidates to possess)

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

Education and Experience (minimum required for consideration)

HS Diploma / GED or Associate's Degree minimum required

At least 2-4 years of work experience in a customer facing role

Demonstrated knowledge of quality and regulatory practices strongly encouraged

Soft Skills (Communication / Team / Leadership)

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

Interview Process : First-Round 30 min Video Interview, Second-Round Onsite Panel Interview

About us :

DivIHN , the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.