Sr. Manager, Post Market QA

SeaSpine is uniquely transforming Spinal Surgery with safe, fast, real-time solutions that give surgeons and hospital partners the confidence to deliver better outcomes to improve patient lives-NOW. If you are interested in being a part of our amazing journey as a member of the Human Resources Team, please read on!

The position is responsible for overseeing Post Market Quality Assurance activities for Spinal Instrumentation and Orthobiologics products. The position includes oversight of post market activities including complaint management, adverse event reporting, post market surveillance, Health Hazard Evaluations (HHE) and field actions. The position also includes ownership of the Risk Management process. The Sr. Manager, Post Market QA ensures post market feedback is incorporated into product development and sustaining activities improving the performance of SeaSpine's products.

Your key responsibilities

• Provide oversight of complaint handling function to ensure timely and compliant complaints entry, investigation, communication and adverse event reporting to all applicable regulatory agencies.
• Assign Health Hazard Evaluations based on complaint and production feedback.
• Provide oversight of recall activities as required.
• Ensure product issues identified from post market activities are considered in the development of new products or assessment of product changes.
• Provide oversight of the Risk Management process including development of appropriate Risk Management tools (AFMEA/DFMEA/PFMEA) consistent with applicable regulatory standards.
• Prepare Post Market information for Quality Management Reviews and Operational Reviews such as: Trend charts, Pareto Analysis, etc., as required.
• Evaluates non-conformances to drive appropriate corrective actions.
• Participate in FDA inspections, Notified Body audits, and other regulatory and customer audits representing Post Market as a subject matter expert.
• Identify and implement opportunities for continuous improvement. Interact and coordinate activities with other departments, external vendors and/or customers. Assist or lead in the prompt implementation of Quality related projects including:
  • Non-Conformance resolution, Complaint Investigation and Corrective & Preventative Action(s) (CAPA), Process Validations.
  • Development and implementation of new and updated Quality System procedures for compliance with ISO/QSR and other applicable regulatory requirements.
• Budget and Team performance assessment and development.
• Other duties as assigned by Manager.

Who you are

• High School Diploma or equivalent and Technical Certification in Healthcare related field
• Bachelor's Degree in related field preferred
• 15 years working in the medical device industry
• Must possess and demonstrate an excellent understanding of medical device Quality System requirements including 21CFR820, 21CFR Part 1270 and 1271, ISO13485, ISO14971 and AATB standards.
• Demonstrated ability in supervising Quality professionals. Ability to work with, coach, and mentor team members.
• ASQ Certifications preferred

We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, color, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age, protected medical condition, genetic information, disability, or any other protected status in accordance with all applicable federal, state, and local laws.

This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.