Senior Quality Assurance Specialist

Company Description

Cipher Surgical is a medical device company established in 2010, known for launching the OpClear platform used in laparoscopic procedures. The OpClear platform ensures continuous intra-abdominal vision for the surgical team, resulting in fewer surgical errors and shorter operating times. Utilizing automated CO2 flow and on-demand saline lens wash, the OpClear platform minimizes the need for scope removal during procedures and quickly clears larger visual obstructions such as blood or particles from energy plumes. This innovative solution enhances the surgical flow and overall efficiency throughout each procedure.

Role Description

This is a full-time on-site role for a Senior Quality Assurance Specialist, located in Chantilly, VA. The Senior Quality Assurance Specialist will be responsible for overseeing and managing quality assurance processes, ensuring compliance with industry standards and regulations. Day-to-day tasks include conducting quality audits, managing quality management systems, implementing Good Manufacturing Practices (GMP), and developing and maintaining quality control protocols. This role also involves collaborating with cross-functional teams to continually improve product quality and ensure excellence in manufacturing standards.

Qualifications

• Quality Assurance, Quality Control, and Quality Management skills
• Experience with Good Manufacturing Practice (GMP) and Quality Auditing
• Strong analytical and problem-solving abilities
• Excellent communication and interpersonal skills
• Ability to work collaboratively with cross-functional teams
• Bachelors degree in a related field or equivalent experience
• Experience in the medical device industry is a plus
• Knowledge of regulatory standards and compliance in the healthcare industry

5+ years of Medical Device experience. ISO 13485

Must be based in Chantilly, VA