Quality Engineer - Additive Manufacturing & Packaging

Lincotek Group; Kentucky; On-site; USD 80,000 - 115,000; Full time

Job summary

Lincotek Group is seeking a Quality Engineer to bring new products and processes to market on time and within budget, with emphasis on packaging validation, process qualification, and continuous improvement.

You will collaborate across engineering, operations and suppliers to ensure ISO 13485 and FDA 21 CFR 820 compliance, perform root cause analysis, and drive corrective actions while fostering a culture of quality and accountability.

Qualifications

• Bachelor’s degree in Engineering or related field required.
• 3–5 years in regulated manufacturing (medical device, aerospace, or equivalent).
• Experience with IQ/OQ/PQ and FMEA/Control Plan.
• Knowledge of ISO 13485 and 21 CFR 820.
• Packaging validation and sterile barrier qualification experience.
• Strong analytical and communication skills.

Responsibilities

• Lead process qualifications and validations per ISO 11607 and ISO 13485.
• Act as quality reference for additive manufacturing and packaging.
• Drive action closure from kickoff meetings and cross‑functional teams.
• Develop and maintain quality procedures, inspection plans, control plans, and FMEAs.
• Support audits and supplier qualification activities.
• Monitor metrics and lead continuous improvement initiatives.

Skills

Quality engineering

Process validation

Root cause analysis

ISO 13485

FDA 21 CFR 820

Lean Six Sigma

GD&T

ERP systems

Education

Bachelor’s degree in Engineering

Master’s degree (preferred)

Tools

ERP systems (SAP/Oracle)

Job description

Lincotek Group is seeking a Quality Engineer to bring new products and processes to market on time and within budget, with emphasis on packaging validation, process qualification, and continuous improvement.

You will collaborate across engineering, operations and suppliers to ensure ISO 13485 and FDA 21 CFR 820 compliance, perform root cause analysis, and drive corrective actions while fostering a culture of quality and accountability.