Quality Engineering Manager
Location: Charlotte, North Carolina
Working Situation: Onsite
A mid-size biotech is a skilled and experienced Quality Engineering Manager to join our team. The Quality Engineering Manager will be responsible for overseeing the quality engineering activities related to the design, development, and manufacturing of medical devices, ensuring compliance with regulatory standards and company quality policies. The ideal candidate will possess strong leadership abilities, technical expertise, and a thorough understanding of quality management systems in the medical device industry.
The Quality Engineering Manager will have the following responsibilities...
- Provide leadership and guidance to the quality engineering team, fostering a culture of collaboration, accountability, and continuous improvement.
- Develop, implement, and maintain quality management systems (QMS) in accordance with regulatory requirements, including ISO 13485, FDA QSR, and other applicable standards.
- Establish and maintain procedures for document control, change management, risk management, and corrective and preventive actions (CAPA).
- Lead quality engineering activities throughout the product development lifecycle, including design input, verification and validation, risk management, and design transfer.
- Collaborate with cross-functional teams to ensure that quality requirements are incorporated into product specifications and design documentation.
- Conduct design reviews and provide input to ensure products meet regulatory and quality standards.
- Develop and maintain supplier quality management processes, including supplier qualification, auditing, and performance monitoring.
- Work closely with suppliers to address quality issues, drive continuous improvement, and ensure adherence to quality agreements and specifications.
- Provide technical expertise and support to resolve quality-related issues, investigations, and non-conformances, utilizing root cause analysis and problem-solving methodologies.
- Lead and participate in internal and external quality audits, ensuring compliance with regulatory requirements and industry standards.
The Quality Engineering Manager should have the following qualifications...
- Bachelor's degree in Engineering or related field; advanced degree preferred.
- Minimum of 8 years of experience in quality engineering within the medical device industry
- In-depth knowledge of quality management systems, regulatory requirements (ISO 13485, FDA QSR), and industry standards applicable to medical devices.
- Strong understanding of design control processes, risk management principles, and validation and verification methodologies.
- Experience managing supplier quality and conducting supplier audits.
- Excellent leadership, communication, and interpersonal skills.
- Proven ability to effectively manage multiple projects and priorities in a fast-paced environment.
Benefits:
- Competitive Salary
- Healthcare benefit package
- competitive PTO package
If you are interested in the Quality Engineering Manager, don't hesitate to apply!
