Lincotek Dayton_Quality Engineer_In AOP

Lincotek-Group; Vandalia (OH); On-site; USD 65,000 - 90,000; Full time

Job summary

Lincotek-Group in Vandalia, OH is seeking a Quality Engineer to bring new products and processes to market on time and within budget, with a strong focus on process qualification, product quality, packaging validation, and continuous improvement.

This role collaborates across engineering and operations, leading root cause analyses and driving Lean/Six Sigma initiatives to ensure regulatory and customer requirements are met while fostering a culture of quality and accountability.

Qualifications

• Process qualifications and validations (including packaging validation) per ISO 11607/ISO 13485 and customer requirements.
• Lead root cause analysis and corrective/preventive actions (8D, 5 Whys).
• Support internal and supplier audits to verify compliance with QMS (ISO 13485, FDA 21 CFR Part 820).
• Monitor quality metrics and drive continuous improvement using Lean and Six Sigma methods.

Responsibilities

• Lead and support process qualifications and validations, including packaging validation per ISO 11607, ISO 13485, and customer requirements.
• Act as quality reference for additive manufacturing, coatings, packaging, and assembly applications for internal and external customers.
• Read, analyze, and interpret customer and regulatory specifications; manage qualification kickoff meetings and drive actions to closure.
• Develop, revise, and maintain quality procedures, inspection plans, control plans, FMEAs, and work instructions.
• Establish and maintain document control practices in support of product assurance and regulatory compliance.
• Implement inspection and test methods, including sampling plans and acceptance criteria, ensuring alignment with industry standards.
• Lead root cause analysis and corrective/preventive actions (8D, 5 Whys) to permanently eliminate nonconformities.
• Support internal and supplier audits to verify compliance with QMS and customer requirements.
• Monitor and analyze key metrics (Quality, Rework, Scrap Cost) and implement continuous improvement initiatives using Lean and Six Sigma.
• Provide training to production and quality personnel on quality procedures, inspection techniques, and regulatory awareness.
• Support vendor qualification and material approval activities by coordinating with suppliers to resolve quality issues and ensure compliance with specifications.
• Participate in customer and notified-body audits.

Job description

The Quality Engineer is responsible for bringing new products and processes to market on time and within budget, with strong focus on process qualification, product quality, packaging validation, and continuous improvement. This role works cross-functionally with engineering, operations, and external partners to ensure compliance with regulatory, customer, and internal requirements, while fostering a culture of quality and accountability. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Lead and support process qualifications and validations, including packaging validation (protocol development, execution, data analysis, and reporting) per ISO 11607, ISO 13485, and customer requirements.
• Act as lead quality reference for internal and external customers regarding additive manufacturing, coatings, packaging, and assembly applications.
• Read, analyze, and interpret customer and regulatory specifications; manage qualification kickoff meetings and drive actions to closure.
• Develop, revise, and maintain quality procedures, inspection plans, control plans, FMEAs, and work instructions.
• Establish and maintain effective document control practices in support of product assurance and regulatory compliance.
• Implement inspection and test methods, including sampling plans and acceptance criteria, ensuring alignment with industry standards
• Lead root cause analysis and corrective/preventive actions (8D, 5 Whys) to permanently eliminate nonconformities.
• Support internal and supplier audits to verify compliance with Quality Management System (ISO 13485, FDA 21 CFR Part 820) and customer requirements.
• Monitor and analyze key metrics (Quality, Rework, Scrap Cost) and implement continuous improvement initiatives using Lean and Six Sigma tools.
• Provide training to production and quality personnel on quality procedures, inspection techniques, and regulatory awareness.
• Support vendor qualification and material approval activities by coordinating with suppliers to resolve quality issues and ensure compliance with specifications.
• Participate in customer and notified-body audits.
• Other duties as assigned.