Quality & Compliance Coach - Senior Manager

Job Description

Day-to-Day Responsibilities

• Serve as the onsite Quality & Compliance Coach for the manufacturing facility
• Lead quality walks and observations to reinforce quality culture and process discipline
• Coach leaders and subject matter experts on regulatory requirements, quality systems, and compliance expectations
• Prepare the site for FDA inspections, Notified Body audits, and other regulatory assessments
• Support Front Room and Back Room audit activities, including inspection strategy and execution
• Identify compliance gaps and help drive corrective actions related to Warning Letter remediation efforts
• Partner with Manufacturing, Quality, Regulatory Affairs, Engineering, and Operations teams to improve quality performance
• Evaluate quality data, audit findings, and operational trends to identify risks and improvement opportunities
• Drive sustainable QMS practices and strengthen overall system effectiveness
• Support CAPA investigations, root cause analysis, and continuous improvement initiatives
• Develop and deliver coaching, training, and mentoring programs to improve site-wide quality competency
• Promote accountability, ownership, and compliance-focused behaviors throughout the organization
• Ensure ongoing inspection readiness through proactive assessments and process improvements
• Support management review activities and quality leadership initiatives

Skills and Requirements

• Bachelor's degree in Engineering, Life Sciences, or a related technical field

• 15+ years of experience within FDA-regulated medical device manufacturing

• Extensive background in Quality Management Systems (QMS), compliance, and regulatory requirements

• Prior experience serving as a Management Representative or equivalent senior quality leadership role

• Significant experience supporting and leading FDA inspections and Notified Body audits

• Demonstrated expertise with both Front Room and Back Room audit processes Strong working knowledge of:

• FDA 21 CFR Part 820

• QMSR

• ISO 13485

• EU MDR

• ISO 14971

• CAPA

• PFMEA

• Root Cause Analysis

• Nonconformance Management

• Quality Notification Processes

• Proven experience driving inspection readiness and audit preparation efforts

• Strong coaching, mentoring, and team development experience

• Ability to influence leaders, SMEs, and cross-functional teams

• Experience building quality culture and organizational competency in manufacturing environments

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].