Principal Quality Engineer — Regulated Medical Devices

Katalyst-Healthcares-; Birmingham (AL); Presencial; USD 110.000 - 140.000; Jornada completa

Descripción de la vacante

Creative Solutions Services, LLC in Birmingham, AL seeks a Principal Quality Engineer to lead quality initiatives across manufacturing and product development, ensuring regulatory compliance and continuous improvement. You will drive CAPA, risk management, design controls, and supplier quality, mentor engineers, and partner with regulatory affairs to support FDA inspections and ISO audits.

This role demands deep knowledge of cGMP, ISO 13485, and Lean Six Sigma, with hands-on experience in

Formación

• Bachelor's degree in Engineering required; 8+ years in regulated manufacturing quality engineering.
• Strong knowledge of FDA, ISO 13485, ISO 9001, and cGMP.
• Experience with Design Controls, ISO 14971, CAPA, change management.
• Hands-on IQ/OQ/PQ, SPC, MSA, and capability studies.

Responsabilidades

• Lead quality engineering activities supporting product development, manufacturing, and sustaining engineering.
• Develop and implement quality strategies that comply with FDA, ISO 13485, ISO 9001, and other applicable requirements.
• Drive root cause investigations and CAPA using structured problem-solving methodologies.
• Lead risk management activities including DFMEA, PFMEA, risk assessments, and mitigation plans.
• Review and approve ECOs, design documentation, validation protocols, and quality records.
• Support design control activities including Design Verification & Validation (V&V), Design Reviews, and DHF.
• Analyze quality metrics and implement CI initiatives using Lean Six Sigma and statistical tools.
• Lead process validation activities including IQ, OQ, PQ, and process capability studies.
• Collaborate with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and Operations to resolve quality issues.
• Provide technical leadership during internal, customer, and regulatory audits.
• Mentor and coach Quality Engineers and cross-functional teams on quality best practices.
• Support supplier qualification, supplier audits, and supplier quality improvement initiatives.
• Ensure compliance with cGMP, FDA Quality System Regulation (21 CFR Part 820) and international standards.

Conocimientos

Quality Engineering

Regulatory compliance

Root cause analysis

CAPA

Design controls

Lean Six Sigma

Statistical analysis

Cross-functional collaboration

IQ/OQ/PQ

FDA regulations

Educación

Bachelor's degree in Engineering

Master's degree in Engineering

Herramientas

Minitab

Descripción del empleo

Job Description:
We are seeking an experienced Principal Quality Engineer to lead quality engineering initiatives that ensure compliance, product quality, and continuous improvement across manufacturing and product development processes. The ideal candidate will provide technical leadership in quality systems, risk management, validation, CAPA, supplier quality, and regulatory compliance while partnering with cross-functional teams to drive operational excellence.
Responsibilities:

• Lead quality engineering activities supporting product development, manufacturing, and sustaining engineering.
• Develop and implement quality strategies that comply with FDA, ISO 13485, ISO 9001, and other applicable regulatory requirements.
• Drive root cause investigations and corrective and preventive actions (CAPA) using structured problem-solving methodologies.
• Lead risk management activities including DFMEA, PFMEA, risk assessments, and mitigation plans.
• Review and approve engineering change orders (ECOs), design documentation, validation protocols, and quality records.
• Support design control activities including Design Verification & Validation (V&V), Design Reviews, and Design History Files (DHF).
• Analyze quality metrics and implement continuous improvement initiatives using Lean Six Sigma and statistical tools.
• Lead process validation activities including IQ, OQ, PQ, and process capability studies.
• Collaborate with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and Operations to resolve quality issues.
• Provide technical leadership during internal, customer, and regulatory audits.
• Mentor and coach Quality Engineers and cross-functional teams on quality best practices.
• Support supplier qualification, supplier audits, and supplier quality improvement initiatives.
• Ensure compliance with cGMP, FDA Quality System Regulation (21 CFR Part 820/QMSR), and applicable international standards.

Requirements:

• Bachelor's degree in Engineering (Mechanical, Biomedical, Industrial, Manufacturing, Electrical, Chemical, or related discipline).
• 8+ years of Quality Engineering experience in a regulated manufacturing environment.
• Strong knowledge of FDA regulations, ISO 13485, ISO 9001, and cGMP requirements.
• Experience with Design Controls, Risk Management (ISO 14971), CAPA, Client, and change management.
• Hands-on experience with process validation (IQ/OQ/PQ), statistical analysis, SPC, MSA, and capability studies.
• Strong knowledge of Lean Manufacturing, Six Sigma, and continuous improvement methodologies.
• Excellent root cause analysis skills utilizing 8D, Fishbone, 5 Whys, and similar tools.
• Experience leading cross-functional projects and mentoring engineering teams.
• Strong written, verbal, and presentation skills.

Preferred Qualifications:

• Master's degree in Engineering or related technical field.
• ASQ Certified Quality Engineer (CQE), Six Sigma Green Belt or Black Belt.
• Experience in medical devices, pharmaceuticals, biotechnology, aerospace, automotive, or other highly regulated industries.
• Experience supporting FDA inspections and ISO certification audits.
• Knowledge of validation documentation, statistical software (Minitab), and quality management systems.