Senior Manager, Quality Operations (Onsite)

This is an onsite role based in Redmond, Washington.

About the Role

As the Senior Manager, Quality Operations, you will lead the team responsible for quality process execution, issue resolution, performance monitoring, and continuous improvement initiatives. You will partner across functions to ensure quality systems remain effective, compliant, and aligned with business objectives while supporting product quality and patient safety. This position is responsible for leading quality systems and process excellence activities, managing quality performance across the organization, supporting regulatory compliance, and developing teams that ensure consistent execution of quality processes and continuous improvement initiatives.

Responsibilities

• Lead day-to-day quality system activities, ensuring quality issues, investigations, and corrective actions are evaluated, documented, and resolved in a timely manner.
• Establish and monitor quality performance metrics, key performance indicators, and reporting processes to identify trends and drive continuous improvement.
• Manage product quality, safety, complaint, and corrective action processes, ensuring compliance with applicable regulatory and quality requirements.
• Develop and implement quality process improvements, standardization initiatives, and operational strategies to improve efficiency and consistency across the organization.
• Partner with Quality Assurance, Research & Development, Manufacturing, Supply Chain, Commercial, and Finance teams to support business and quality objectives.
• Represent quality systems and processes during internal, external, regulatory, and third-party audits, ensuring audit readiness and effective follow-up actions.
• Develop annual budgets, forecasts, resource plans, and departmental objectives to support organizational priorities.
• Recruit, develop, coach, and manage team members, establishing performance goals and supporting employee development and succession planning.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Quality, Manufacturing, or a related discipline.
• Minimum 10 years of experience in Quality, Quality Systems, Manufacturing Quality, Regulatory Affairs, or a related regulated industry function.
• Minimum 4 years of people leadership experience, including performance management and employee development responsibilities.
• Experience working within a regulated environment governed by FDA, ISO, or other international quality and regulatory requirements.
• Experience managing quality systems, complaint investigations, corrective and preventive action processes, or product quality programs.

Preferred Qualifications

• Master’s degree in Engineering, Science, Quality, Business, or a related field.
• Experience applying Lean, Six Sigma, or other continuous improvement methodologies.
• Experience with enterprise resource planning systems, including SAP, Oracle, or JD Edwards.

Pay

$155,900 - $259,800 USD Annual

Benefits

• Health benefits: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program, and tobacco cessation program.
• Financial benefits: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.