Quality & Regulatory Support Specialist (Remote)

Job Description

Job Description

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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For further inquiries regarding the following opportunity, please contact our Talent Specialist, Hari at View phone number on ziprecruiter.com

Title: Quality & Regulatory Support Specialist (Remote)
Location: Remote
Duration: 3 Months

Must be able to work either 6 AM - 3 PM or 7 AM - 4 PM Monday-Friday

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

Job 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, predominantly for our customers in Europe.

Support of customer communications regarding complaints and audit requests. Facilitate customer audit requests working with customers and Plant Quality to schedule on-site and remote audits. Assure that all necessary components and agreements are in place prior to customer audit.

Act as liaison between customers and other Client departments and functions.
Responsible for supporting the projects and ongoing processes associated with Quality and Regulatory Services (QRS)

Day to Day Responsibilities:
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

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 & 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
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
Experience designing and maintaining reports and metrics
Knowledgeable in use of ETQ, Sharepoint, Salesforce.com, SAP, and PeopleSoft.
Passion for innovation, automation, and continuous improvements
Multi-lingual skills highly desired

Education and Experience (minimum required for consideration)
Bachelor's degree, Life Sciences, Chemistry or Engineering or related field of study preferred.
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

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.