Manufacturing Quality Engineer

• Quality Systems & Regulatory: Strong knowledge of ISO 13485, ISO 14971, and FDA 21 CFR Part 820 / QMSR requirements.
• Risk Management & FMEA: Strong understanding of risk-management principles and experience with FMEA.
• Problem Solving & Root Cause Analysis: Ability to investigate manufacturing and quality issues, identify root causes, and drive effective solutions.
• Communication & Cross-Functional Influence: Ability to collaborate effectively across Quality, Engineering, Manufacturing, Operations, and other functional teams.
• Manufacturing Quality & Process Knowledge: Hands-on manufacturing quality experience with a strong understanding of production processes and quality requirements.

• Support validation and certification of new process equipment and periodic reviews of certified systems.
• Implement and maintain the effectiveness of the Quality System.
• Ensure quality goals, procedures, and practices comply with company policies and applicable regulations.
• Lead and support investigations of plant events, including product impact assessments and CAPA activities.
• Support QA holds and other quality actions when appropriate.
• Participate in Validation Review Board activities as the Manufacturing Quality representative.
• Review and approve SOPs to ensure compliance and practical application.
• Review calibration requests and ensure appropriate product/process limits are established.
• Develop and implement statistical quality programs and acceptance sampling plans.
• Maintain strong working relationships with Quality, Manufacturing, Engineering, and other Plant departments.

• Bachelor's Degree in Engineering, Biology, Chemistry, or related field, or equivalent relevant experience.
• 2+ years of experience in Manufacturing, Quality, Engineering, or a related field.
• Experience in a regulated manufacturing environment preferred.
• Strong verbal and written communication skills.
• Strong problem-solving and analytical abilities.
• Good interpersonal, collaboration, and negotiation skills.
• Knowledge of quality/compliance requirements and regulations affecting API, bulk drug, or finished goods manufacturing.

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.