This position provides to Lubrizol’s quality system for the design, development and manufacturing of finished medical devices. The Quality Engineer provides product engineering support by assessing risk, process capabilities, developing and implementing effective quality assurance controls. The Quality Engineer must have a “hands-on” approach to continuous improvement of the quality system and implementation and Quality Assurance management of design control process, problem solving, problem investigation and data mining.
Duties & Responsibilities:
Develops, writes, and implements effective quality assurance controls
Writes and reviews validation and verification plans and protocols, assists with IQ/OQ/PQ activities, including finalize reports
Compiles and reviews Design History Files and Master Device Records.
Coordinates the identification, assignment, monitoring, and completion of process and product improvement projects.
Works with the operations and engineering functions to coordinate pilot production of new products
Coordinates the reporting, analysis, and resolution of material nonconformance occurrences
Applies statistical and quality tools to analyze data and perform thorough Root Cause Analysis, executes CAPA processes and improves process capabilities
Completes projects in a manner consistent with corporate objectives
Provides support in the rapid resolution of product complaints and/or safety issues.
Develops and conducts training programs regarding company quality systems.
Provides quality assurance appraisal of suppliers.
Conducts quality process and product audits; develops responsive corrective action plans.
Documents current practices to meet quality requirements necessary for QMS for medical devices.
Provides specific support for operational quality management system programs.
Performs other required duties as needed in addition to the essential duties and responsibilities described above.
Required Skills & Experience
Bachelor’s degree in an engineering or technical discipline with at least 5 years’ experience in manufacturing, research and development, engineering, or quality
Experience in medical device industry
Hands-on experience in an FDA-regulated environment
Experience using tools of root cause analysis and defect analysis, including failure mode and Effect Analysis for process and product design.
Proficiency in Microsoft Office
Experience developing and implementing process controls, corrective and preventive action, and product and process quality improvement.
Experience with DOE, SPC, Lean, cGMP &/or Six Sigma
Experience with quality management systems.
Able to lead and influence others to drive change.
Strong written and verbal communication skills
Project planning and management skills
Considered a Plus:
Experience with new product development
Experience with plastics/thermoplastics
Experience with verification and validation activities.
Experience with cost estimating based on labor, material and variable overhead inputs.
Experience with Design History Files, Risk Management and design output documentation.
Understanding of ISO 13485 21CFR Part 820 and proficiency with design control requirements.
The Lubrizol Corporation, a Berkshire Hathaway company, provides unmatched science that unlocks immense possibilities at the molecular level. Our solutions are found in products used by people every day, driving sustainable and measurable results to help the world Move Cleaner, Create Smarter and Live Better.