Note: Candidates with HACCP experience exclusively in the food industry will not be considered. Experience must be from the pharmaceutical and/or medical device industry.
We are seeking an experienced Quality Assurance Engineer with strong expertise in HACCP, FMEA, Risk Management, and Contamination Control within the pharmaceutical or medical device industry. Candidates with experience only in the food industry will not be considered. The ideal candidate will have hands-on experience implementing quality systems, conducting risk assessments, and ensuring compliance with FDA regulations and GMP requirements.
Key Responsibilities
- Develop, implement, and maintain HACCP programs for pharmaceutical or medical device manufacturing processes.
- Perform FMEA (Failure Mode and Effects Analysis) and risk assessments to identify, evaluate, and mitigate product and process risks.
- Support Risk Management activities throughout the product lifecycle in accordance with regulatory and quality standards.
- Lead contamination control initiatives, including environmental monitoring, cleanroom practices, and aseptic process improvements.
- Ensure compliance with FDA 21 CFR Parts 210 and 211, cGMP, and internal Quality Management System (QMS) requirements.
- Participate in investigations involving deviations, non-conformances, complaints, CAPA, and root cause analysis.
- Collaborate with Manufacturing, Engineering, Validation, Regulatory Affairs, and Quality Control teams to drive continuous quality improvements.
- Review and approve SOPs, validation protocols, risk assessments, and quality documentation.
- Support internal and external audits, including FDA, ISO, and customer audits.
- Monitor quality metrics and recommend corrective and preventive actions to improve compliance and product quality.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, Microbiology, Pharmaceutical Sciences, or a related field.
- 3+ years of Quality Assurance experience in the pharmaceutical or medical device industry.
- Hands-on experience with HACCP in pharmaceutical or medical device manufacturing.
- Strong experience performing FMEA and formal Risk Management activities.
- Experience with contamination control, cleanroom operations, and cGMP manufacturing.
- Thorough knowledge of FDA 21 CFR Parts 210 & 211, GMP, and Quality Systems.
- Experience with CAPA, deviations, investigations, root cause analysis, and change control.
- Excellent documentation, communication, and problem-solving skills.
Preferred Qualifications
- Experience in sterile manufacturing, aseptic processing, or combination products.
- Knowledge of ISO 13485, ISO 14971, or other medical device quality standards.
- ASQ Certified Quality Engineer (CQE) or related quality certification is a plus.
Indeed Search Keywords
HACCP, Quality Assurance, QA Engineer, Pharmaceutical Quality, Medical Device Quality, FMEA, Risk Management, Contamination Control, FDA 21 CFR 210, FDA 21 CFR 211, cGMP, GMP, CAPA, Root Cause Analysis, Quality Systems, Validation, Deviations, Non-Conformance, ISO 13485, ISO 14971, Cleanroom, Aseptic Manufacturing, Pharmaceutical Manufacturing, Medical Device Manufacturing.
Pay: $45.00 per hour
Experience:
- HACCP: 5 years (Required)
- Contamination control: 5 years (Required)
- FMEA: 5 years (Required)
Work Location: Remote
