Quality Assurance Engineer
Planet Pharma Group
- Middletown, Ohio, United States
- Middletown, Ohio, United States
À propos
Key Responsibilities Quality Systems & Compliance
Ensure compliance with ISO 13485, ISO 14971, FDA 21 CFR 820, EC GMP , and other applicable regulatory requirements
Support internal, external, customer, and regulatory audits , including preparation and follow‑up activities
Maintain and continuously improve quality procedures, work instructions, and documentation
Manufacturing & Process Support
Provide quality engineering support across molding, assembly, inspection, and packaging processes
Lead process validations (IQ, OQ, PQ) and maintain validation documentation
Participate in PFMEA, Control Plans, and risk management activities
Support containment, investigation, and resolution of nonconformities
Continuous Improvement
Lead root cause investigations using tools such as 8D, Fishbone, and 5 Whys
Implement and manage Corrective and Preventive Actions (CAPA) and verify effectiveness
Drive continuous improvement initiatives using Lean and Six Sigma methodologies
New Product Introduction (NPI)
Support quality planning and risk assessments for new product development and transfers
Review customer specifications, drawings, and validation requirements
Ensure quality deliverables are completed to meet project timelines and milestones
Supplier & Customer Quality
Support supplier qualification, audits, and performance monitoring
Investigate customer complaints and ensure timely, compliant resolution
Collaborate with customers to improve quality and enhance satisfaction
Required Qualifications Education
Bachelor’s degree in Engineering, Quality, Science, or a related field
Experience
2-5+ years of quality engineering experience in a regulated manufacturing environment
Preferred industries: medical device, pharmaceutical, or healthcare packaging
Experience with molding or precision manufacturing processes is a plus
Technical Skills
Strong knowledge of:
ISO 13485
FDA 21 CFR 820
ISO 14971 risk management
Process validation (IQ/OQ/PQ)
Experience with statistical tools and SPC
Proficiency in Microsoft Office ; experience with eQMS systems preferred
Key Competencies
Strong analytical and problem‑solving skills
High level of attention to detail and documentation accuracy
Ability to work effectively in a cross‑functional, fast‑paced environment
Clear and professional written and verbal communication skills
Proven ability to manage multiple priorities and deadlines
Preferred Certifications
ASQ Certified Quality Engineer (CQE)
Six Sigma Green Belt or higher
ISO 13485 Lead Auditor certification
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Compétences linguistiques
- English
Avis aux utilisateurs
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