Quality Engineer - Additive & Packaging Validation

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

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.