Operations Quality Engineer in Minneapolis

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Job DescriptionJob Description

Job Title: Operations Quality Engineer

Department: Quality

About Us:

We are a contract manufacturer offering medical device prototyping, development, and manufacturing. Our primary capabilities are balloon catheters, delivery systems, reinforced and steerable catheters, nitinol components, and biomedical textiles.

Summary:

The Operations Quality Engineer will work closely with customers and the manufacturing team to ensure problems that arise in Receiving Inspection (RI) and the manufacturing lines are addressed quickly, and corrective actions are implemented. A focus of the role will be on continuous improvement and mistake proofing to ensure manufacturing lines run effectively and efficiently. Assignments include resolving and trending NCMRs, customer complaints, and Supplier Corrective Actions (SCARs), completing root cause analysis, and implementing Corrective and Preventative Actions (CAPA). In addition, the Operations Quality Engineer will generate and execute process validation protocols (IQ/OQ/PQ) as well as support process risk management activities (pFMEA).

Essential Duties and Responsibilities (but are not limited to):

• Function as the operation’s quality customer representative when projects are transferred to manufacturing
• Supporting design transfer, verification of readiness for production, and ensuring quality requirements are fully implemented.
• Lead NCMR, customer complaints and CAPA investigation and reports; including trouble shooting manufacturing problems and ensuring compliance to procedures and requirements.
• Collaborate with suppliers as needed on NCMRs and SCARs, escalating to Supplier Quality Engineering when appropriate.
• Participate in cross-functional teams for the review and disposition of nonconforming products or components.
• Participate in cross-functional teams to develop process validation and risk management files, including IQ/OQ/PQ protocols and reports and pFMEA documentation.
• Review completed Device History Record (DHR) documentation with a high degree of accuracy for Good Documentation Practices (GDP) and completeness.
• Support and advise project teams on Quality Policies / Procedures (including verification, validation, statistical methods, and manufacturing controls), when necessary.
• Assist in training of Special Work Orders (SWOs), Receiving Inspection Processes, and First Article Inspections (FAI) as required
• Develop and implement error-proofing mechanisms (poka-yokes) to prevent defects and improve manufacturing processes.
• Assist in internal and process audits; may lead portions of audits as assigned.

Technical Skills:

• Extensive expertise in manufacturing operations and quality systems in a medical device environment.
• Understanding ISO 13485 and FDA QSR requirements including root cause analysis, risk management, and process validation.
• Root Cause Analysis (RCA) includes ability to define problems, collect data, establish facts and draw valid conclusions.
• ISO 13485 Lead Auditor certification .
• Experience in eQMS systems, preferably Grand Avenue Software (GAS).
• Experience with error proofing techniques (poka-yokes) and their implementation in manufacturing environments.
• Highly proficient with MS Office (Word, Excel, Access and PowerPoint), internet and e-mail systems. Solid understanding of software capabilities and business applications.
• Ability to accurately prioritize and execute with minimal direction.
• Ability to interpret and understand drawing specifications, tolerances, procedures for inspection and the application of sampling plans.
• Familiar with the ability to use inspection devices such as pin gauges, micrometers, calipers, pressure gauges, rules and microscopes.
• Excellent communication skills (written and verbal).

Conceptual Skills:

• Creative problem solver coupled with good judgment.
• Independent work skills.
• High attention to detail and accuracy.
• Ability to manage, prioritize and execute multiple tasks.
• Positive, flexible outlook.
• Strong interpersonal communication skills with the ability to effectively communicate across all levels.

Education/Experience:

• Requires a B.S. degree in Science, Engineering or Technology or associated fields.
• Working knowledge of medical device regulations (FDA 21CFR820, ISO 13485, ISO 14971).
• Working knowledge of the application of risk management, include pFMEA and process validation.
• 3-5 years’ experience in Quality Engineering.
• 5+ years’ experience in the medical device industry. Catheter assembly .

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