Quality Assurance Engineer
1 week ago
This position is pivotal in fulfilling the quality assurance requirements of the organization. Key responsibilities encompass compliance evaluation, risk assessment, process validation, and the validation of various protocols, including CAPA, among others. The role necessitates collaboration with operational teams, supply chain management, and new product development initiatives.
Key Responsibilities:
- Ensure adherence to regulations for medical device manufacturing, including ID/Traceability, management of non-conforming materials, and process validation.
- Conduct risk assessments, participate in project meetings, oversee First Article Inspections, and manage risk effectively.
- Develop and implement procedures for product and equipment inspection and testing.
- Carry out pFEMA's, IQ, OQ, PQ, and PPQ validation processes.
- Oversee Corrective and Preventive Actions, drive process enhancements, and facilitate training programs.
- Coordinate both internal and external audit processes.
Qualifications:
- Bachelor's degree in a relevant field such as science or engineering.
- A minimum of 10 years of pertinent experience.
- At least 5 years of experience in the medical device manufacturing sector.
- Comprehensive understanding of Quality Systems policies and industry regulations.
- Experience with supplier audits and contractual agreements.
- Proficiency in statistical analysis methodologies.
Company Overview:
AJR Enterprises, LLC is a leading contract manufacturer specializing in medical devices and advanced manufacturing solutions. Our commitment to delivering superior quality products and ensuring client satisfaction is at the core of our operations in the medical device sector.
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