The role of Quality Engineer is integral to the on-going compliance of the manufacturing and distribution processes. The Quality Engineer is involved in all stages of the product life cycle --- Product design, manufacturing support, and post-launch maintenance.
Ensures that new products are properly integrated into the existing quality system.
Leads efforts in conjunction with manufacturing and engineering to develop plans for continual improvement of product and process quality.
Ensures that decisions are made based on sound Quality principles and regulatory guidelines.
Supports/leads investigations and corrective action efforts.
Promotes use of statistical analysis for determination of improvements, and provides analyses to support risk mitigation.
Evaluates complaint trends to drive improvements, assisting in their investigation as necessary.
Independently leads failure investigations, using root cause analysis tools, and proposing/implementing systemic corrective actions.
Uses Lean/six sigma tools to identify areas of improvement, specifically related to process controls by using relevant statistical tools to analyze data for proactive improvements.
Provides routine analysis of performance indicators. Presents this information to management, supervisors, and manufacturing operators.
Guides engineering/manufacturing personnel in establishment of appropriate qualification, validation criteria.
Role has no budget responsibility for department spending
Size of Team: individual contributor
Responsibility is limited to Greenville Location
Internal customers/partners: Operations, Distribution, Commercial, Planning, Compliance, Engineering
External customers: Regulatory Agencies and Notified Bodies
Four-year college degree (BA/BS) in fields such as life, physical sciences, or engineering
Certifications preferred: CQA, CQE, CQM
5+ years Quality experience, 3 years minimum in medical devices or pharmaceutical manufacturing. Strong verbal and written communication skills, ability to manage multiple priorities. Working knowledge of 21CFR820, 21CFR210/211, ISO 13485, ISO 9001, Quality tools, and problem solving tools, statistical analysis.
Experience in leading, conducting and writing investigations