Quality Assurance Specialist
About The Position
The Quality Assurance Specialist leads timely customer complaint investigations and supports the Quality team in processing complaints uniformly and promptly. The role assigns and ensures thorough investigations with detailed, accurate statements. It also supports final lot history reviews and issuance of Certificates of Conformance (CoC) for customer shipments. The specialist evaluates complaint products and related records, communicates with customers to obtain information, coordinates root cause analysis with subject matter experts, and supports corrective and preventive actions. The role also performs product inspections, maintains quality KPIs and dashboards, and follows applicable safety guidelines.
Requirements
- Associate's degree, or high school diploma or GED with equivalent experience or training.
- Three to five years of manufacturing-related experience in a regulated industry.
- Three to five years of experience in visual and dimensional evaluation of molded products, or in plastic injection molding and assembly processes.
- Ability to work in a fast-paced environment.
- Ability to coordinate and work closely with cross-functional teams to develop and execute thorough, timely corrective and preventive action plans.
- Strong computer skills, including proficiency with Windows, word processing software such as Word and Excel, and database applications.
- Strong IQMS knowledge.
- Knowledge of gauging and metrology.
- Blueprint-reading ability.
- Ability to read and write in English.
- Ability to read and interpret basic engineering drawings and product specifications.
- Prior manufacturing-environment experience to understand normal safety requirements.
Nice To Haves
- Experience or knowledge of quality systems relating to 21 CFR Parts 820 and ISO 13485 or ISO 9001.
Responsibilities
- Accurately enter customer complaint information reports into the IQMS CAR module.
- Evaluate and investigate customer complaints and complaint products thoroughly and promptly.
- Trend customer complaints and communicate trends to management weekly, monthly, quarterly, and annually.
- Follow up with customers by phone or email to obtain information needed to investigate complaints.
- Examine device history records, manufacturing records, and other original source records as appropriate to support complaint investigations.
- Perform initial probable cause analysis and alert management to identified nonconformances.
- Communicate technical information verbally and in writing.
- Coordinate and lead complaint root cause analysis with subject matter experts to support corrective and preventive actions.
- Support stakeholder departments in efforts required for complaint resolution.
- Measure and inspect complaint products against retain samples, product drawings, materials, and production specifications.
- Perform basic dimensional and cosmetic inspection techniques using tools such as calipers and micrometers.
- Read and understand product drawings, work instructions, engineering specifications, and inspection documents.
- Develop and maintain applicable KPIs and dashboards supporting departmental goals and objectives.
- Coordinate and support final lot history reviews and issuance of Certificates of Conformance (CoC) for customer shipments.
- Follow safety guidelines applicable to the work area.
- Perform related duties and other assignments as required by the Quality Engineer or managers.
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What This Job Offers
Job Type
Full-time
Education Level
Associate degree
