Quality and Regulatory Services Specialist

Our Client, a Business Maunufacturing and Supply company, is looking for a Quality and Regulatory Services Specialist for their Remote location.

Responsibilities:

• Responsible for providing frontline 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)
• 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
• 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

Requirements:

• 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, SAP, and PeopleSoft.
• Passion for innovation, automation, and continuous improvements
• Multi-lingual skills highly desired
• 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
• 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

Why Should You Apply?

• Health Benefits
• Referral Program

Excellent growth and advancement opportunities