Senior Quality Systems Specialist - huMannity Medtec

At HuMannity Medtec, we pioneer life-enhancing medical technologies for undermet healthcare needs. Come join our team of engineers, scientists and medical device experts who are inspired to develop innovative solutions for tomorrow’s challenges. If you’d like to join a high-reward, truly inspiring environment with an experienced, diverse team working at their best every day, and take your career to the next level, apply today!

We truly understand the need for balance and, among other things and offer a 9/80 schedule with every other Friday off. That’s 26 long weekends a year

We are looking for an experienced and highly motivated Senior Quality Systems Specialist to join our Quality Assurance team and help us improve processes, increase efficiency, and maintain our ISO 13485 certification.

Position summary:

The Senior Quality Systems Specialist will work closely with R&D, Manufacturing, and Quality Assurance to monitor and improve quality efforts. Develop and update SOPs in compliance with ISO 13485 and FDA 21 CFR Part 820. Coordinate and maintain the nonconformance, corrective/preventative action and external reference programs. Analyze, gather, and trend quality data. Promote quality assurance, and quality control policies and activities in partnership with key technical groups to ensure product quality and regulatory compliance. Must have a good working knowledge of 21 CFR Part 820, and ISO 13485:2016.

Main responsibilities:

• Prepares and implements quality assurance, policies, and procedures.
• Develops and updates Standard Operating Procedures (SOPs), Work Instructions, Forms amongst other documents in compliance with ISO 13485:2016 requirements.
• Assists in external and internal audits and performs follow-ups for identified nonconformances.
• Monitors CAPAs, Performs Root Cause Analysis and CAPA Verifications.
• Monitors and maintains external standards and performs reviews per internal SOPs.
• Monitors Quality Objective status and progress.
• Monitors progress and timely completion, execution and closure of Quality Plans.
• Analyzes, gathers and trends quality data for KPIs and Management Review meetings.
• Supports continuous improvement activities.
• Supports eQMS maintenance of quality system modules such as CAPA and Audits.

Education/Experience:

• Bachelor’s degree and/or a combination of 5+ years’ practical and educational experience in the medical device industry.
• Must have experience with ISO 13485:2016
• Must have experience with eQMS software
• Must be very detail-oriented, and work well with Engineering, Manufacturing, Quality and R&D personnel.
• Advanced computer skills and experience working with Microsoft Office Professional including Word, Excel, PowerPoint, Vizio, and database programs.
• Ability to work independently on multiple assignments with competing priorities.
• Good understanding of 21 CFR Part 820 preferred