Quality Assurance Specialist

Responsibilities:

• Accurately enter Customer Complaints information reports into IQMS CAR modules.
• Responsible to trend and periodic communication (weekly, monthly, quarterly and annual) to manage Customer Complaint trends
• 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.
• 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.
• 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

Qualifications:

• Requires an Associate’s degree or equivalent experience/training in lieu of a High School Diploma or GED.
• At least 3 years of experience working in a regulated manufacturing industry.
• 3+ years of experience in evaluating molded products, including visual and dimensional assessments, or familiarity with plastic injection molding and assembly processes.
• Knowledge of Quality Systems, such as those related to 21 CFR Parts 820 and ISO 13485 or 9001, is preferred.
• Prior experience in a manufacturing setting with an understanding of standard safety protocols is required.