QMS Manager

About the role

The Ultrasound QMS Manager oversees the strategic management of the QMS department, aligning it with organizational goals and industry best practices. They analyze QMS performance data to identify trends, systemic issues, and improvement opportunities, and lead cross-functional teams in developing and implementing effective solutions to enhance quality and compliance.

Responsibilities

• Analyzes QMS performance data to identify trends, systemic issues, and improvement opportunities, and lead cross-functional teams in developing and implementing effective solutions to enhance quality and compliance.
• Serves as a senior quality advisor and key point of contact for regulatory bodies, ensuring that QMS processes and practices are fully compliant, and effectively managing external audits, inspections, and follow-up actions.
• Led and managed complex, high-impact problem-solving initiatives using advanced quality tools and methodologies such as Six Sigma or Lean, ensuring effective resolution of critical quality issues and sustainable improvements.
• Manages talent across the team, while driving employee selection, performance management, compensation management, career development, and ensuring effective operational management.
• Oversees the management and resolution of non-conformance reports (NCRs), ensuring systematic tracking, thorough investigation, effective resolution, and implementation of preventive measures.
• Covers risk assessments and risk management activities, identifying significant risks to product quality and QMS integrity, and developing and implementing robust mitigation strategies.

Requirements

Requires a Bachelor's or Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent. 5+ years of experience with Bachelor's in areas such as Quality Management Systems, Quality Audits or equivalent in highly regulated environments/industries such as Medical Device, Pharma, Automotive. 5+ years of experience in leading teams with direct and indirect reports in complex matrix organizations and delivering on organizational objectives.

Qualifications

Must be able to successfully perform the following minimum physical, cognitive and environmental job requirements with or without accommodation for this Office/Remote position.

Skills

Advanced quality tools and methodologies such as Six Sigma or Lean.

Benefits

Details about our benefits can be found here.

Pay

The pay range for this position in Cambridge, MA is $134,000 to $186,000 Annually. The pay range for this position in Bothell, WA is $134,000 to $186,000 Annually. The pay range for this position in Reedsville, PA is $120,000 to $170,000 Annually. The pay range for this position in Plymouth, MN is $126,000 to $175,000 Annually. The pay range for this position in San Diego, CA is $134,000 to $186,000 Annually.

Schedule

This is an office role.