Quality Manager {SE}

ARCH Medical Solutions Memphis is looking for a Quality Manager that will oversee all aspects of quality management, compliance, and continuous improvement initiatives to uphold the highest standards of our Quality Management System.

Responsibilities:

• Support quality assurance strategies, policies, and procedures to ensure compliance with regulatory requirements (e.g., FDA, ISO standards) and industry best practices.
• Ensure quality management system (QMS) policies are being implemented and followed.
• Lead and mentor a team of quality assurance professionals, providing guidance, training, and support to drive a culture of quality excellence and continuous improvement.
• Collaborate with cross-functional teams (e.g., engineering, manufacturing, regulatory affairs) to ensure alignment of quality objectives with business goals and customer requirements.
• Oversee quality control activities, including inspection, testing, and validation of raw materials, in-process components, and finished products to verify compliance with specifications and standards.
• Conduct risk assessments, root cause analyses, and corrective/preventive action (CAPA) initiatives to address quality issues and drive process improvements.
• Manage quality audits and inspections conducted by regulatory agencies, customers, and external auditors, ensuring readiness and compliance with audit requirements.
• Monitor key performance indicators (KPIs) related to quality metrics, analyze trends, and implement corrective actions as needed to enhance product quality and operational efficiency.
• Drive continuous improvement initiatives through the use of quality tools and methodologies (e.g., Lean Six Sigma, DMAIC) to optimize processes and reduce variability.
• Maintain documentation and records related to quality management activities, including quality plans, procedures, validation protocols, and audit reports.

Qualifications:

• Bachelor’s degree in Quality Assurance, or related field; advanced degree or equivalent experience preferred.
• Typically 10 years of progressive experience in quality assurance and quality management roles within the medical device manufacturing industry.
• In-depth knowledge of regulatory requirements applicable to medical devices (e.g., FDA QSR, ISO 13485) and experience in managing regulatory inspections and audits.
• Strong leadership and team-building skills with a proven track record of leading and developing high-performing quality teams.
• Excellent problem-solving and analytical skills, with the ability to apply quality tools and methodologies to drive continuous improvement and problem resolution.
• Effective communication skills, with the ability to collaborate and influence cross-functional teams and senior management.
• Experience with implementing and maintaining quality management systems (QMS) and proficiency in using quality management software applications.
• Demonstrated commitment to quality, compliance, and customer satisfaction.

Additional Notes:

ARCH Medical Solutions is an Equal Opportunity Employer and wholeheartedly supports diversity in the workplace as a basic premise for business success. All employees of Arch Medical Solutions are employed on an at-will basis.

This job description in no way states or implies that these are the only duties to be performed by the employee incumbent in this position. Employees will be required to follow any other job-related instruction and to perform any other job-related duties requested by any person authorized to give instructions or assignments.

A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skill, or abilities.