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# Lead Quality Engineer

- **Company:** Katalyst Talent Agency
- **Location:** Fort Wayne, IN, United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Failure Mode Effects Analysis, Minitab, Statistical Process Control (SPC), JMP (Statistical Software)
- **Published:** September 16, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=8ff4acf3f25f83ae

## About the Role

* Bachelor's degree in engineering, Quality, Manufacturing, Mechanical, Biomedical, Industrial Engineering, or related field.
 * 7+ years of Quality Engineering experience, preferably in medical device, pharmaceutical, biotech, or other regulated manufacturing environments.
 * Strong knowledge of Quality Management Systems and regulatory requirements.
 * Experience with CAPA, nonconformance, root cause analysis, risk management, and process validation.
 * Hands-on experience with PFMEA/DFMEA, SPC, MSA, Gage R&R, and Control Plans.
 * Strong analytical, problem-solving, project management, and communication skills.
 * Experience leading cross-functional teams and quality improvement projects., * ASQ Certified Quality Engineer (CQE) certification.
 * Lean Six Sigma Green Belt or Black Belt certification.
 * Experience with FDA 21 CFR Part 820 and ISO 13485.
 * Experience with Minitab, JMP, or other statistical software.
 * Experience with Design Controls and medical device product development.
 * Experience with supplier quality and manufacturing transfers.
 * Master's degree in Engineering or Quality-related discipline preferred.

## Description

* Lead and provide technical direction for Quality Engineering activities across manufacturing and product development.
 * Develop, implement, and maintain quality plans, procedures, and engineering controls.
 * Lead CAPA, nonconformance, deviation, complaint, and root cause investigations.
 * Support and lead process validation, equipment qualification, and test method validation activities.
 * Develop and review PFMEA, DFMEA, risk assessments, control plans, and inspection plans.
 * Support Design Controls, Verification & Validation (V&V), NPI, and Design Transfer activities.
 * Lead continuous improvement initiatives using Lean, Six Sigma, SPC, DOE, and statistical analysis.
 * Monitor process capability, quality metrics, defects, and trends to identify improvement opportunities.
 * Provide quality engineering support for manufacturing process development and sustaining engineering.
 * Lead supplier quality activities, including supplier qualification, audits, corrective actions, and performance improvement.
 * Ensure compliance with FDA regulations, ISO 13485, GMP, and applicable quality standards.
 * Support internal, supplier, and regulatory audits.
 * Review and approve quality and validation documentation.
 * Collaborate with R&D, Manufacturing, Operations, Regulatory, Supply Chain, and Supplier Quality teams.
 * Provide technical guidance, mentoring, and training to junior Quality Engineers.
 * Lead moderately to highly complex quality projects and ensure delivery within established timelines.


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