Quality Assurance Specialist

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Quality Sites DCS Full Time Fishers, IN, US

Quality Specialist primarily is responsible to lead timely customer complaints investigations, support Quality team to ensure that complaints are processed in a uniform and timely manner. This position is responsible for assigning and ensuring that complaint investigations are thorough and are written with detailed, accurate statements in a timely manner. This position also supports coordination of final lot history review and issuance of Certificates of Conformance (CoC) to support customer shipments.

• Accurately enter Customer Complaints information reports into IQMS CAR module
• Perform thorough evaluation, investigation of customer complaints and complaint product in a timely manner. Responsible to trend and periodic communication (weekly, monthly, quarterly and annual) to management Customer Complaint trends weekly, monthly and quarterly
• Follow up with customers by phone or email to obtain all necessary information to effectively investigate each complaint.
• Examine the device history record, manufacturing records and other original source records as appropriate towards supporting evidence of Customer Complaints. Perform initial probable cause analysis and alert management to any nonconformance found.
• Must be able to communicate technical information, both verbal and written.
• Coordinate and lead complaint root cause analysis with SMEs to support corrective and preventive actions measures.
• Support other key stakeholder departments in additional efforts required in the complaint resolution process.
• Measure and inspect complaint product against retain samples, product drawings, materials and production specifications.
• Able to perform basic dimensional and cosmetic inspection techniques on products, such as calipers, micrometers, etc.
• Must be able to read and understand product drawings, work instructions, engineering specifications and inspection documents.
• Develop and maintain applicable KPIs and dashboards to support departmental Goals and Objectives
• Coordinate and support final lot history review and issuance of CoC to support customer shipments
• Follow safety guidelines applicable to the area.
• Perform related duties as required.
• Other assignments as may be given by the Quality Engineer or Managers.
• PC literate and demonstrate proficiency in Windows, word processing software, (Word, Excel), and other database applications
  
  Core Competencies:
• Thorough understanding of Customer Complaint Investigations as applicable to 21 CFR part 820 regulations, ISO 13485 and ISO 9001 standards.
• Ability to work in a fast paced environment
• Ability to coordinate and work closely with cross functional teams to develop and execute thorough and timely corrective and preventive action plans.
• Gaging and Metrology
• Read and write in the English language.
• Ability to read and interpret basic engineering drawings and product specifications.

• Associate’s degree or High School Diploma or GED with equivalent experience/training is required
• Minimum 3-5 years of manufacturing related experience in a regulated industry.
• Minimum 3-5 years of experience in visual and dimensional evaluation of molded products; or in plastic injection molding and assembly processes.
• Experience or knowledge in Quality Systems relating to 21 CFR Parts 820 and ISO 13485 or 9001 is preferred
• Should have prior experience in a manufacturing environment to understand normal safety requirements.