RQM+ · 6 days ago

Quality Engineer

United States - Remote

Full-time

Remote

Mid Level

3+ years exp

Maximize your interview chances

Health CareMedical

Insider Connection @RQM+

Discover valuable connections within the company who might provide insights and potential referrals.
Get 3x more responses when you reach out via email instead of LinkedIn.

Responsibilities

Support the management of the Quality Management System (QMS) to ensure compliance with applicable standards, regulations, and company expectations.

Develop, implement, administrate and maintain quality assurance processes and procedures, ensuring they align with the company’s QMS, regulatory requirements, and industry standards.

Lead and support internal and external audits, ensuring that the company is adequately prepared for regulatory inspections and certifications.

Conduct risk assessments for new and existing processes, services or products; collaborating with cross-functional teams to implement effective risk management strategies.

Lead and support various verification and validation activities, ensuring that manufacturing and service processes meet all regulatory and quality standards.

Manage corrective and preventive action processes, investigating product defects, non-conformances, and customer complaints, and ensuring that corrective actions are effectively implemented.

Perform root cause analysis and collaborate with teams to implement corrective and preventive actions to enhance product quality and process efficiency.

Evaluate, qualify, and monitor suppliers, ensuring their products and processes meet both company and regulatory standards, and manage supplier quality issues as needed.

Provide regular reports on quality metrics and key performance indicators (KPIs) to senior management, tracking trends, compliance, and the effectiveness of quality initiatives.

Drive continuous improvement of the QMS, identifying, defining, and implementing process enhancements and tools to optimize quality performance and efficiency.

Providing leadership, mentoring, and/or coaching others in best practices of quality principles and methodologies; including those adopted by the organizational quality system.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Quality Management System (QMS)ISO 9001 complianceRoot cause analysisProcess ImprovementQuality assurance processesRegulatory inspectionsCertified Quality Engineer (CQE)Quality management softwareCross-functional collaborationProject management

Required

Bachelor’s degree in quality assurance, technical or related field.

Minimum 3-5 years of quality system experience in a regulated industry, medical device (preferred) or ISO 9001 environment.

Experience leading multiple projects in a fast-paced environment

Strong analytical and problem-solving skills, with the ability to perform root cause analysis and drive continuous improvement.

Excellent communication skills, both written and verbal, with the ability to present complex quality issues clearly to cross-functional teams and management.

Proficient in the use of quality management software and tools

Strong attention to detail and a proactive approach to identifying and resolving quality issues.

Ability to coach, teach and lead others; work cross-functionally in a matrix organization

Ability to manage multiple projects and highly adaptable to business needs

Strong understanding of quality system management