We are supporting a senior-level opportunity for a quality professional to strengthen compliance culture, drive audit readiness, and help close warning letter gaps at a regulated manufacturing site. Our team is seeking someone who can coach leaders and teams, improve quality system execution, and support sustained readiness across day-to-day operations and inspections.
Responsibilities:
Lead quality walks and reinforce disciplined, compliance-focused behaviors across the site. Coach site leaders, SMEs, and teams on regulatory expectations and sustainable quality practices. Drive inspection readiness activities, audit preparation, and real-time support during front room and back room events. Partner with Manufacturing, Quality, Regulatory, Engineering, and Operations to identify risks and improve quality performance.
Required:
Bachelor's degree in Engineering, Life Sciences, or a related technical field. 15+ years of experience in FDA-regulated medical device manufacturing, with extensive focus on QMS compliance, inspection readiness, internal audit, CAPA, and process/continuous improvement. Deep subject matter expertise in
QMSR, FDA 21 CFR
Part 820, ISO 13485, EU
MDR, ISO
14971, PFMEA, root cause analysis, CAPA, nonconformances, and quality notification processes. Demonstrated Front Room and Back Room audit expertise, including inspection strategy, communication flow, request management, SME preparation, evidence review, and real-time inspection support. Experience serving as a Management Representative or in an equivalent quality leadership role with accountability for QMS effectiveness, management review, and health authority or Notified Body inspection readiness. Extensive experience leading or supporting regulatory inspections, including FDA inspections and Notified Body audits, in complex manufacturing or global matrix environments.
About SSI People:
With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from SSi People and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: SSi People Privacy Policy
