Quality Engineering Leader — Med Device Aesthetics

Bausch Health; Bothell (WA); On-site; USD 115,000 - 158,000; Full time

Benefits offered by this job

Medical Insurance

Dental & Vision

401(k) matching

Tuition Reimbursement

Paid Holidays

Stock Purchase Plan

Parental Leave

Disability Insurance

Life Insurance

Job summary

Solta Medical in Bothell, WA is seeking a Senior Manager, Quality Engineering to lead the Quality Engineering, Supplier Quality and Receiving Inspection teams. You will develop goals, procedures, and systems aligning with FDA/ISO regulations and the company mission.

The role emphasizes process validation, CAPA, risk management, and continuous improvement to ensure the highest quality for medical devices. Reporting to the Director of Quality Operations, you will drive collaboration across R&D,

Qualifications

• Bachelor's degree in sciences or technical field.
• Minimum of 7 years medical device industry experience.
• Minimum of 5 years of management experience.
• Extensive knowledge of government regulations for QMS.
• Experience with ISO 9001/EN 46001, ISO 13485, MDR, CE marking and IEC 60601.
• Strong collaboration, negotiation and conflict resolution skills.
• CAPA, supplier management and risk management experience.
• Multi-tasking with strong planning and accountability.

Responsibilities

• Attract and retain talent for Quality Engineering and supplier quality teams.
• Create a culture of quality compliant with QMS, FDA QSR, ISO, MDR and international requirements.
• Support audits and inspections by regulatory agencies and notified bodies.
• Drive process validation, test method development, statistical analysis and improvement projects.
• Strategically drive CAPAs, non-conformances and risk management activities focusing on process improvement.
• Prioritize decisions balancing schedule, scope and cost.
• Partner with R&D, Maintenance, Operations, QA and other functions to resolve quality issues and achieve high-quality results.
• Lead oversight of the nonconformance system and mentor in root-cause analysis.
• Mentor continuous improvement to prevent issues and resolve them economically.

Skills

Leadership

Project management

Regulatory knowledge

CAPA

Supplier management

Education

Bachelor's degree in science/engineering

Job description

Solta Medical in Bothell, WA is seeking a Senior Manager, Quality Engineering to lead the Quality Engineering, Supplier Quality and Receiving Inspection teams. You will develop goals, procedures, and systems aligning with FDA/ISO regulations and the company mission.

The role emphasizes process validation, CAPA, risk management, and continuous improvement to ensure the highest quality for medical devices. Reporting to the Director of Quality Operations, you will drive collaboration across R&D,