• Receive and process potential customer complaints and maintain a customer complaint system in compliance with US FDA regulations utilizing a complaint handling software package for all Draeger devices distributed in the US.
• Independently review/evaluate customer complaints to determine and document Medical Device Reporting decisions in accordance with US FDA regulations.
• Work independently and/or interface directly with other Draeger functional departments, local subsidiaries, field service and clinical personnel, as well as customers to effectively accumulate necessary potential complaint information.
• Review service calls, material returns, phone logs and other sources of customer feedback for potential customer complaints
• Monitor the status and progression of complaints under investigation and monitor the Complaint Product Return Goods process for efficiency and effectiveness, providing feedback concerning areas of deficiency
• Assist in the generation of detailed Complaint Database reports and/or Complaint status information for management review.
• Assist with coordinating activities pertaining to proactively addressing emerging and potential customer issues in the USA. Interface directly with the customer by providing written and/or verbal responses to complaints.
• Assist in determining, developing, and implementing policies/procedures for appropriate, comprehensive, and effective quality system and regulatory compliance in support of Draeger’s vigilance system.
• Assist during internal IMS audits and during external audits performed by customers and regulatory agencies.
• Perform other duties as needed and assigned.

Education:

Technical, Associates degree or equivalent experience required.

Related Experience:

3-5 years’ experience in a medical device company, preferably in a Regulatory or Quality related role. Technical knowledge of medical devices a plus.

In North America, Draeger employees over 1,400 employees working in our major sites in the United States and Canada (in the US: Andover, MA; Telford, PA; Houston / Coppell, TX, and in Canada: Mississauga, ON), including our Sales and Service workforce employees from coast to coast.

Our US headquarters located north of Philadelphia in Telford, Pennsylvania is our US manufacturing site for our Neonatal product line supplying many global customers as well as production support for Draeger’s Safety products. This location also serves as the key site for essential US functions which includes Medical Sales and Service Management, Medical Marketing, Legal, Compliance, Regulatory, Quality and Finance.

Equal Opportunity Employer – Disability and Veteran

Draeger is a leading international company in the fields of medical and safety technology. Whether in clinical applications, in industry, mining or emergency services: Draeger products protect, support and save lives. That's what our more than 15,000 employees have been striving for - every day for more than 130 years. Dräger - Technology for Life ®

• Health Insurance
• Retirement Savings
• Special Assistance
• Additional/Voluntary Insurance
• Education & Training
• Health center and gym
• Time Away
• Workplace Wellness