Staff Quality Systems Specialist I
$135,500–$216,800 year
On-siteConcord, North Carolina, United States
Job Summary
Develop and update site procedures and policies while serving as the Site CAPA Leader and Subject Matter Expert for Trackwise utilization. Lead site Audit Manager duties by collaborating with internal audit teams to assess risks, ensure audit requirements are met, and manage pre- and post-inspection activities including logistics, coaching, and response tracking. Act as the coordinator for Quality Notifications, support root cause analysis and problem-solving, and track trends across quality data sources to drive continuous improvement initiatives. Manage Management Review content development and maintain site and worldwide quality systems through cross-functional collaboration with engineering, operations, and medical teams.
Required Qualifications
- BS degree in Engineering, Science, or other related discipline
- At least 8 years of medical device, biologic, pharmaceutical, or diagnostic industry experience
- Strong knowledge of US and International regulations and standards that apply to the medical device industry including 21CFR820, ISO 13485, MDD/MDR, MDSAP country requirements as well as other requirements applicable to the product
- Proficient communication, organizational and interpersonal skills
- Ability to perform multiple tasks and prioritize workload
- Self-motivated / directed, require minimum supervision
- Effective analytical, technical, and problem-solving skills
- Effective meeting and presentation skills
- Ability to perform and/or host internal / external audits
- Collaborative ability to work in teams to obtain desired results
- Minimum of 4 days of in-office presence per week
- Proof that you are fully vaccinated against COVID-19
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