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Team Lead (Complaint Investigations)

Company: USDM Life Sciences, LLC
Location: Santa Barbara
Posted on: July 12, 2019

Job Description:

SunIRef:it Team Lead (Complaint Investigations) USDM Life Sciences, LLC - Santa Barbara, CA USDM Life Sciences is a leading global consulting firm focused on life sciences, specializing in regulated business processes, with an emphasis on compliance and performance. We are seeking Complaint Investigators with medical device industry experience. Remote role after two weeks of paid onsite training. You are responsible for: Evaluate, investigate, track and complete complaints through effective and established complaint handling process. Ensure accurate documentation of evaluation and investigation results with the assigned complaint records. Collaborate with Engineering, Customer Support, Field personnel, Market Service Order reviewers and other appropriate groups for adequate initial evaluation of complaints. Participate and collaborate objectively with productive conclusions in the Complaint Handling Unit meetings. Coordinate with the reportable complaint investigators in providing any missing information for root cause activities. Collaborate with Adverse Event Coordinators for reportable complaints as well as Product Safety Committees for Correction and Removal process. Assist in trending of complaints and collaborate with the appropriate groups to ensure that the data gets pushed to the appropriate departments for actions. Support reviews and audits assigned. Identify and drive process-related improvements related to compliance and efficiency gains Communicate with and support customers (external end users, internal direct and indirect sales representatives, business development, marketing, and engineering) by processing and analyzing business-related customer feedback information. Efficiently collect and process customer feedback information into the feedback and complaint handling tools to ensure compliance with internal procedures and external regulations. Provide superior customer support in terms of warranty product replacement, suggesting alternative product solutions, providing instructions for use, etc. with the goal to delight our customers with products and support. Communicate with the customer to facilitate the return of allegedly defective devices via the RMA process. Prepares responses to customers and field as necessary per process. Work with the Post Market Surveillance Manager for any other projects assigned. You are a part of: To succeed in this role, you should have the following skills and experience. 1-5 years of experience in a medically regulated and technical environment or related experience. BS in an engineering discipline or equivalent education, experience, training. Demonstrated strong results orientation. Proficiency using statistical tools, office tools, and various other computer software applications. Must be able to work under pressure to meet regulatory reporting time frames and company requirements. Strong sense of responsibility and self-motivation with demonstrated ability to function independently and in a group environment. Requires the proven ability to consistently meet and/or exceed goals. Must be capable of making commitments, setting prior. About USDM Life Sciences, LLC USDM is a leading global professional services firm focused exclusively on providing business process, technology and compliance solutions for the regulated life science industry. USDM's professionals are recognized thought leaders in emerging life science computer system topics. They are experts in improving business value through the implementation and adoption of new technologies that run regulated business processes. USDM is a place where you can find the mentoring and support to develop and establish a career. USDM is seeking high potential people to develop into high impact people to meet USDM's mission of making a sustainable impact in regulated life sciences and doing the best work of their life. It is our goal to employ the best candidates in the industry and allow them to have dynamic and exciting careers by fostering mentorship by USDM Practice and Engagement leaders and the opportunity to learn new skills in various settings! As a leading global compliance firm, our employees get a chance to make an impact on key life science firms. We have all of the standard benefits that you would expect from a large company, like health insurance and retirement benefits and so on. Fine-tune your expertise - USDM has many training opportunities with our practices and large partner network. We have 13 practices with over 22 partners including Oracle, SAP, Microsoft and many more. Partners: Accelrys, Agilent Technologies, AX for Pharma, Box, Bioclinica, Camstar, CSC, Docusign, Extendo, Generis, HP, Innovocommerce, Inspirage, Kalido, Kneat, Microsoft, Nextdocs, Opentext, Oracle, Qumas, Salesforce, SAP, Servicemax, Trackwise, Veeva and Vmware. Areas of expertise: Project Management, Business Analysis, Data Integrity, Digital Transformation, Validation, Auditing, Lab Support, GCP. GMP, GXP, Quality Assurance, Clinical, SQA, UDI, Regulatory Please contact me today, either by email at ***************, Inmail or by calling my direct line at **************. USDM Life Sciences, LLC - 23 hours ago - report job - original job If you require alternative methods of application or screening, you must approach the employer directly to request this as Indeed is not responsible for the employer's application process.

Keywords: USDM Life Sciences, LLC, Santa Barbara , Team Lead (Complaint Investigations), Other , Santa Barbara, California

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