Quality Assurance Manager - Arizona, United States - i-Pharm GxP

Description

QC Manager - Medical Device Partner

Job Description

• Our client, a leading Medical Device manufacturer, is seeking an experienced QC Manager to join their team on a contract basis. This is an excellent opportunity for a quality assurance professional to contribute to the success of a dynamic and innovative organization. As the QC Manager, you will be responsible for overseeing the quality control processes and procedures for the client's medical device production. This is a hands-on role that requires a deep understanding of quality management systems, regulatory compliance, and continuous improvement methodologies.

Key Responsibilities:

• Develop and implement comprehensive quality control plans, including sampling strategies, inspection protocols, and testing procedures
• Ensure compliance with all relevant quality standards, regulations, and industry best practices (e.g., ISO 13485, FDA QSR, cGMP)
• Manage a team of quality control technicians and inspectors, providing guidance, training, and performance feedback
• Collaborate with cross-functional teams, including production, engineering, and regulatory affairs, to identify and resolve quality-related issues
• Analyze quality data, identify trends, and implement corrective and preventive actions to continuously improve the quality management system
• Maintain detailed quality records and documentation, and prepare reports for management and regulatory authorities
• Provide technical expertise and support to the client's quality assurance team, and serve as a subject matter expert on quality-related matters
• Participate in audits, inspections, and other quality-related activities, and ensure timely and effective responses to any findings or observations

Qualifications and Experience:

• Bachelor's degree in a relevant field, such as Engineering, Quality Assurance, or a related discipline
• Minimum 5-7 years of experience in a quality control or quality assurance role within the medical device industry
• Proven track record of successfully managing quality control processes and teams in a regulated manufacturing environment
• In-depth knowledge of quality management systems, regulatory requirements, and industry best practices
• Excellent problem-solving, decision-making, and project management skills
• Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams
• Proficient in the use of quality management software, data analysis tools, and quality control documentation
• Ability to work independently, adapt to changing priorities, and thrive in a fast-paced, dynamic environment

If you are a seasoned quality control professional with a passion for medical device manufacturing, we encourage you to apply for this exciting contract opportunity. This is a chance to make a significant impact on the client's quality management system and contribute to the development of innovative medical technologies.