Quality Specialist III

Work Schedule

Environmental Conditions

COMPANY: Thermo Fisher Scientific Inc.

LOCATION: 8365 Valley Pike, Middletown, VA 22645

TITLE: Quality Specialist III

HOURS: Monday to Friday, 8:00 am to 5:00 pm

DUTIES: Receive, review, and investigate complaints related to medical devices by gathering relevant information, analyzing data, and conducting root cause analyses.
Ensure customer complaint investigations are complete, accurate and closed in a timely manner; including meeting regulatory requirements.
Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, Product Development, and Risk Management, to resolve complaints and identify improvement opportunities.
Connect with customers to address concerns and provide updates on complaint resolution.
Supervise complaint trends and find opportunities for product improvement.
Ensure compliance with applicable regulations and standards, such as FDA 21 CFR Part 820 and ISO 13485.
Prepare for and participate in internal and external audits.
Provide matrix/project leadership, training and guidance to junior team members.
Maintain accurate records.
Participate in cross-functional business process improvement activities as the need arises.
Work with cross-functional teams to drive technical solutions for medical device problem-solving.
Participate in risk management activities, including Failure Mode and Effects Analysis (FMEA), to identify and mitigate potential risks associated with product complaints.
Travel: Up to 10% travel required (domestic only).

REQUIREMENTS: MINIMUM Education Requirement: Bachelor’s degree in Biomedical Engineering, Life Sciences, Materials Sciences, or related field of study. MINIMUM Experience Requirement: 3 years of experience in an FDA regulated environment (drugs, biologics, medical devices or related products), or related experience. Required knowledge or experience with: ISO 13485 and GMP regulations which govern a medical device and diagnostics manufacturing; Tracking and trending tools and reporting techniques; Experience creating presentations, working with spreadsheets, preparing reports and writing procedures utilizing MS Word, Excel and PowerPoint software applications; Complaint Management Systems (CMS): Experience with complaint management software like Master Control, TrackWise or Veeva Vault QMS to document, track, and manage complaint investigations; Root Cause Analysis Tools: Experience with tools such as Fishbone Diagrams, 5 Whys, or Failure Mode and Effects Analysis (FMEA) for root cause analysis; Regulatory Submission experience including preparing documentation for regulatory bodies (e.g., FDA, or Notified Bodies) for complaint handling and reporting; and Data Analysis Tools such as Minitab or similar statistical software for trend analysis and continuous improvement efforts related to complaints.