Senior Quality Engineer – Regulatory & Process Excellence

Katalyst-Healthcares-; Baltimore (MD); On-site; USD 150,000 - 210,000; Full time

Job summary

Creative Solutions Services, LLC in Baltimore seeks an experienced Principal Quality Engineer to lead quality systems, risk management, validation, CAPA, supplier quality, and regulatory compliance across manufacturing and product development.

You will partner with cross-functional teams and drive continuous improvement using Lean Six Sigma, providing leadership during audits by FDA and ISO inspections.

Qualifications

• 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, 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.

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 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, Design Reviews, and 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 audits (internal, customer, regulatory).
• 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 QSR (21 CFR Part 820) and applicable international standards.

Skills

Quality Systems Leadership

Regulatory Compliance

CAPA / Corrective Actions

Risk Management (ISO 14971)

Design Controls

Minitab / Statistical Methods

Cross-functional Collaboration

Project Leadership

Education

Bachelor's degree in Engineering

Master's degree (preferred)

Tools

Minitab

Excel / Spreadsheets

Job description

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.