Quality and Regulatory Services Associate

Job Title: Quality and Regulatory Services Associate

Location: Tewksbury, MA

Duration: 06+ Months

Schedule

Full-time, 40 hours expected. M-F, 8am - 5pm OR 10am - 7pm

Job Description

Possibility for hybrid (3 days per week in office) for exceptional candidate once training period is complete. No relocation expenses will be reimbursed.

Interview Process

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

Purpose of Position

• 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 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 & 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,  and People Soft.
• 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

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