Experience:
1-3 years of experience
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Employment Type:
Full time
Posted:
11/3/2016
Job Category:
Customer Service
Industry:
Other
Compensation:
35000.00
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Quality Complaints Investigator
Alliance Scientific Solutions | Cleveland, Ohio
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Job Description

If you are an experienced life sciences professional or just starting your career you need a resource that understands the unique skills of your profession. Alliance Scientific Solutions employs experienced, specialized recruiters that align themselves with our candidates and customers to establish long-term qualified partnerships that generate positive results.

Alliance Scientific Solutions is currently recruiting for a Quality Complaint Investigator for a Global company in the Cleveland area. This is a Direct Hire opportunity, benefits, 401K, and pay up to $35,000 per year!

Overview:

Quality Complaints Investigator is responsible for timely processing complaints, following up on complaint investigations, and monitoring the trends from complaint data.

Essential Duties and Responsibilities:

  • Act as the primary consolidation point for analysing and investigating product complaints.
  • Evaluate, investigate, track and complete complaints through effective and established complaint handling process.
  • Ensure accurate documentation of evaluation and investigation results are within the assigned complaint record.
  • Review and analyze complaint trend data to identify and report recurring issues to the Regulatory Compliance Specialist and Sr. Quality Technician.
  • Communicates with Customer Service and other departments to gain necessary information to investigate notification.
  • Reviews device history records, device master records, incoming inspection records, quality alert and CAPA records for anomalies. User Manuals, Labeling as part of investigation process
  • Perform risk assessment of events in order to determine need for regulatory reporting (requires understanding of product design, function and use); provide acceptable rationales for events for which no reporting is determined to be required.
  • Report any actual or potential safety hazards to the Regulatory Compliance Specialist and Quality Manager.
  • Gain product and process knowledge to understand root cause
  • Assist with other quality/regulatory activities, as needed

Experience:

  • Minimum 3 years customer support or similar experience with progressive responsibilities, including training, problem solving, and report generation.
  • Minimum 2 years work experience in a medical device or pharmaceutical market.

Technical Knowledge or other skills:

  • General awareness of industry regulations (ISO 13485) and cGMPs
  • Excellent Communication skills - verbal and written
  • Experience with Microsoft Office suite and/or Salesforce
  • Demonstrated problem solving skills and implementation of new processes
  • Experience in a team oriented business setting
  • Strong organizational skills
  • Possess the ability to work under pressure and exhibit multi-tasking capabilities to meet regulatory reporting time frames and company requirements.
  • Self-motivated and self-directed
  • Positive attitude
  • Good time management and organizational skills

Alliance Scientific Solutions has partnerships with over one-hundred leading manufacturing companies and we will work hard to find the best fit for your career goals. Whether you are looking for a career in: Pharmaceuticals, Food & Beverage, Clinical Labs, Medical Device or Polymers & Coatings. Submit your application and we will help in connecting you with some the leading technology companies in the United States!

Qualifications

Applicants must be eligible to work in the specified location

This company profile was created by AfterCollege and is about Alliance Scientific Solutions. This page is not endorsed by or affiliated with Alliance Scientific Solutions. For questions regarding company profiles, please email: care@aftercollege.com.