What are the responsibilities and job description for the Quality Engineer – Medical Devices / Pharma position at JobsRUs.com?
Quality Engineer ??? Medical Devices / Pharma
Location : 400 E Foster Rd, Mannford, Ok 74044
Employment Type : 1 year contract
Industry : Medical Devices / Pharmaceuticals
Benefits : 401k
Health, Dental, Vision Insurance
Weekly Pay
Company Overview :
Our client is a leader in the medical devices / pharmaceuticals industry, dedicated to developing high-quality products that improve patient outcomes. We are seeking a highly motivated and detail-oriented Quality Engineer to join our team. If you have experience in GMP and regulatory compliance within a medical or pharmaceutical environment, we???d love to hear from you!
Position Summary :
As a Quality Engineer, you will play a critical role in ensuring the quality and compliance of our products through active involvement in process improvement, validation, and continuous monitoring. You will collaborate with cross-functional teams to resolve production issues, perform data analysis, and ensure all processes meet required regulatory standards.
Key Responsibilities :
Ensure compliance with Good Manufacturing Practices (GMP), FDA, and ISO standards in all stages of product development and manufacturing.
Conduct equipment, process, materials, and method validation to ensure that products meet regulatory and quality standards.
Investigate and resolve production-related issues, utilizing problem-solving techniques and root cause analysis.
Use statistical analysis and metrics to assess and improve processes and product quality.
Write test protocols and reports to validate processes and ensure product functionality and safety.
Support regulatory audits and internal audits to ensure compliance with industry standards.
Collaborate with cross-functional teams (e.g., production, engineering, suppliers) to address quality concerns and improve processes.
Ensure that documentation is clear, accurate, and complies with regulatory standards.
Required Qualifications :
2 years of experience in Quality Engineering or related field within a regulated industry (Medical Devices, Pharmaceuticals, etc.).
Hands-on experience with GMP, FDA, and ISO 9001 / 13485 standards.
Experience with quality control processes, including testing, documentation, and reporting.
Proficiency in statistical analysis and quality tools, such as sample size calculations and root cause analysis.
Ability to work collaboratively with cross-functional teams.
Strong attention to detail and ability to manage multiple tasks and priorities in a fast-paced environment.
Preferred Qualifications :
Experience with Supplier Quality Management is a plus.
Familiarity with statistical software or tools used for quality analysis.
Basic understanding of regulatory audits and compliance activities in medical device or pharmaceutical environments.##
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