Customer Complaints Specialist

1 month ago


San Diego, United States MILLENNIUMSOFT Full time

Job Title - Customer Complaints Specialist (Must Have Trackwise, Complaint Investigations, Trending)

Location - San Diego, CA

Duration – 12+ Months Contract

Total Hours/week - 40.00
1st Shift

Client: Medical Device Company

Job Category: Quality

Level Of Experience: Seniority Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)
Primarily Remote position, but must be local to go onsite as needed – looking to interview and fill quickly.

Description:
3 Must haves on the resume:
-Experience with Trackwise
-Experience with Complaint Investigations
-Experience with Complaint Trending

The Specialist, Customer Complaints is responsible for the completion of all tasks associated with complaint management and processing of event reporting, including communication for regulatory compliance with medical device reporting for both domestic and international agency regulations.

Job responsibilities, not limited to:
• Collaborate with appropriate clinical, technical, and/or regulatory employees to determine product event status and MDR reportability
• Assures timeliness and compliance with all FDA regulations and standards related to the review of events/complaints for BD products
• Write and submit eMDR reports to the FDA and Health Canada in strict adherence with regulatory requirements and timelines.
• Coordinate, research, and prepare correspondence in response to FDA and global regulatory agencies requests for additional information
• Maintain complaint and MDR file documentation in accordance with regulatory requirements. Completes global complaint handling and adverse event reporting activities related to BD products
• Comply with the site Quality System.
• Performs other duties as assigned.

Qualifications
Education & Experience
• Bachelor’s degree (chemistry, engineering, nursing) strongly preferred.
• 1 to 2 years’ experience in Quality, Regulatory or Complaint management is preferred. May consider equivalent combination of education and experience.

Knowledge, Skills & Abilities
• Working knowledge of QA, Regulatory/Quality Compliance in a medical device industry.
• Attention to detail is essential.
• Able to utilize computers for development of reports and summary of project experience.
• Strong proficiency with MS Office tools to include Word, Excel, PowerPoint and Outlook.
• Prior work experience with TrackWise Complaint Handling System preferred.
• Prior experience filing eMDRs preferred.
• Ability to work on multiple projects with various disciplines are essential.
• Ability to multitask in an ever-changing environment.
• Position requires innovative/critical thinking, ability to solve problems and meet deadlines.
• Strong communication, organization, presentation, and writing skills.



  • San Diego, United States MILLENNIUMSOFT Full time

    Job Title - Customer Complaints Specialist (Must Have Trackwise, Complaint Investigations, Trending) Location - San Diego, CA Duration – 12+ Months Contract Total Hours/week - 40.00 1st Shift Client: Medical Device Company Job Category: Quality Level Of Experience: Seniority Level Employment Type: Contract on W2 (Need US Citizens Or GC Holders...


  • San Diego, United States Hologic Full time

    Complaint Investigation Specialist San Diego, CA, United States Hologic, Inc. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases and to aid in biomedical research. Hologic is also a leader in the development, manufacturing and sales of medical imaging systems and...


  • San Diego, United States Hologic Full time

    Complaint Investigation Specialist San Diego, CA, United States Hologic, Inc. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases and to aid in biomedical research. Hologic is also a leader in the development, manufacturing and sales of medical imaging systems and...


  • San Francisco, CA, United States LeadStack Inc. Full time

    As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we're proud to partner with some of the most admired Fortune 500 brands in the world. Location: Remote (candidates must be local - first 3-5 days onsite for training and equipment pickup) San Francisco, CA 94143. Shift: M-F 8:30 AM - 5:00 PM...


  • San Diego, United States Hologic Full time

    Hologic, Inc. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases and to aid in biomedical research. Hologic is also a leader in the development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an...


  • San Diego, California, United States Hologic Full time

    Hologic, Inc. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases and to aid in biomedical research. Hologic is also a leader in the development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an...


  • San Diego, California, United States Hologic Full time

    Hologic, Inc. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases and to aid in biomedical research. Hologic is also a leader in the development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an...


  • San Diego, United States MG Properties Full time

    With over 30 years of experience in the acquisition, development, rehabilitation, and management of apartment communities across the Western United States, we are a trusted partner in the property management industry. At MG Properties, we focus on enriching lives - physically in our community buildings, philanthropically through giving back to our local...


  • San Diego, United States MG Properties Full time

    With over 30 years of experience in the acquisition, development, rehabilitation, and management of apartment communities across the Western United States, we are a trusted partner in the property management industry. At MG Properties, we focus on enriching lives - physically in our community buildings, philanthropically through giving back to our local...


  • San Antonio, Texas, United States Randstad USA Full time

    Randstad is seeking financial professionals for the executive complaints office for a large financial institution in Des Moines. This role is a long-term contract to hire opportunity that starts in office but ultimately transitions to a hybrid model where you will work one week in the office and one week at home. Please apply if you are interested. salary:...


  • San Diego, United States Hawthorne Machinery Co. Full time

    Overview: **We Build Better Communities** **Be Part of the Hawthorne Difference!** Hawthorne Cat is a family-owned company that has led the equipment industry for over 60 years in the sale, rental, and servicing of construction machinery and power generation equipment for industries on which our communities depend like agriculture, construction, marine,...


  • San Diego, United States Gardencommunitiesca Full time

    **Customer Service Specialist** Location **San Diego, CA** * Back up/Support Customer Services Associates (see CSA job description). * Respond to Customer Service emails. Primarily past resident disputes. * Training and continued support of maintenance and leasing staff. * Maintain office supply inventory. * Notifies property manager of repeat tenant...


  • San Diego, United States Gardencommunitiesca Full time

    **Customer Service Specialist** Location **San Diego, CA** * Back up/Support Customer Services Associates (see CSA job description). * Respond to Customer Service emails. Primarily past resident disputes. * Training and continued support of maintenance and leasing staff. * Maintain office supply inventory. * Notifies property manager of repeat tenant...


  • San Diego, United States ABC Imaging Full time

    **Customer Service/Reprographics Specialist** * San Diego, CA * Full-Time * Customer Service/Reprographics Specialist **Job Description**ABC Imaging is a global printing, media, and technology company. Since its inception in 1983, ABC Imaging has grown to operate 33 regional production hubs across the US, Europe, the Middle East, and Asia, employing over...


  • San Diego, United States ABC Imaging Full time

    **Customer Service/Reprographics Specialist** * San Diego, CA * Full-Time * Customer Service/Reprographics Specialist **Job Description**ABC Imaging is a global printing, media, and technology company. Since its inception in 1983, ABC Imaging has grown to operate 33 regional production hubs across the US, Europe, the Middle East, and Asia, employing over...


  • San Diego, United States Fighter's Market Inc Full time

    Fighters Market (www.fightersmarket.com) is a growing Brazilian Jiu-Jitsu Uniforms and Apparel business. Our goal is to provide our customers with a wide variety of Brazilian Jiu-Jitsu supplies at competitive prices and with superior customer service. We are looking for a results-driven retail Sales Associate to be responsible for online AND in-store sales...


  • San Diego, United States Hawthorne Cat Full time

    Overview We Build Better Communities Be Part of the Hawthorne Difference! Hawthorne Cat is a family-owned company that has led the equipment industry for over 60 years in the sale, rental, and servicing of construction machinery and power generation equipment for industries on which our communities depend like agriculture, construction, marine, and...


  • San Diego, United States Hawthorne Cat Full time

    Overview We Build Better Communities Be Part of the Hawthorne Difference! Hawthorne Cat is a family-owned company that has led the equipment industry for over 60 years in the sale, rental, and servicing of construction machinery and power generation equipment for industries on which our communities depend like agriculture, construction, marine, and...


  • San Diego, United States FightersMarket.com Full time

    Fighters Market (www.fightersmarket.com) is a growing Brazilian Jiu-Jitsu Uniforms and Apparel business. Our goal is to provide our customers with a wide variety of Brazilian Jiu-Jitsu supplies at competitive prices and with superior customer service. We are looking for a results-driven retail Sales Associate to be responsible for online AND in-store sales...


  • San Diego, CA, United States Hologic Full time

    Hologic, Inc. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases and to aid in biomedical research. Hologic is also a leader in the development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an...