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Quality Assurance Specialist
4 weeks ago
Job Summary:
The Quality Assurance Specialist ensures continuous quality compliance and improvement within a medical device manufacturing environment. This person will monitor ongoing manufacturing operations to ensure that quality issues are quickly addressed. Will create and maintain quality documentation, as required.
Key Responsibilities:
* Ensures compliance of customer requirements, industry standards, and safety in the workplace.
* Educate operators and production associations on quality and compliance procedures.
* Will interface with customers on quality related matters and improve incoming customer inquiries to reduce Return Material Authorizations (RMAs).
* Support customer audits.
* Understands and follows company quality policy guidelines, customer specifications and adheres to regulatory compliance.
* Focus on eliminating scrap. Keeps supervisors informed and escalates issues when needed.
* Drive Proactive Continuous Improvement on Yield & Quality Metrics by designing templates for documents, file types, and document databases.
* Drive cross-functional teams to deliver continous improvement activities for internal processes and deliverables.
* Provide supervision and guidance to Quality Assurance Inspectors and Technicians.
* Guide Quality Assurance operators, group leaders, and technicians in ongoing quality improvement activities.
Requirements:
* Bachelor's Degree is required, preferably in an Engineering field.
* Relevant previous work experience in Quality Engineering within a manufacturing environment is required.
* Understanding and experience with manufacturing quality tools and processes (e.g., CAPA, FMEA, PPAP, etc.)
* Ability to work well in a fast-paced manufacturing environment.
* Strong ability to identify and solve problems proactively using structured problem-solving tools, including making timely and effective decisions.
* Ability to design and conduct experiments, as well as to analyze, interpret, validate, and communicate data to key stakeholders.
* Any Quality Certifications are a plus (e.g., Six Sigma, CQE, etc.).
* Experience working in a highly-regulated industry is preferred (e.g., medical device, automotive, aerospace, defense, etc.)
Equal Employment Opportunity:
Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.