Quality Assurance Manager Job Description

Alydia Health is a venture-backed, clinical-stage medical device company dedicated to making childbirth safer for all mothers. Our technology has the potential to change obstetric care and reduce the mortality and morbidity associated with postpartum bleeding. Alydia has developed the Jada System, a medical device designed to rapidly stop abnormal bleeding following childbirth. The Jada System was recently cleared by the FDA for marketing in the U.S. Alydia is currently beginning a limited launch of the Jada System in the US. We are a team of dedicated, mission-driven people, and as a small company, every team member at Alydia makes a big contribution towards our mission. We seek candidates who are passionate about improving healthcare and motivated to do the hard and exciting work required to bring a groundbreaking technology to market.

Primary Function of Position:

The Quality Assurance Manager will help establish the direction for the development and administration of Alydia’s quality system. The Quality Assurance Manager will support cross-functional activities to assure compliance with quality system requirements.

Primary Responsibilities:
The position has responsibility and authority for:

• Work closely with VP, Quality Assurance to plan, direct or coordinate quality assurance, programs, formulate quality control policies, and support regulatory affairs activity related to FDA and international filings.
• Coordinate the creation, review, and revision of Standard Operating Procedures to assure compliance with required regulations.
• Coordinate and participate in audits by US FDA, State of California FDB, European notified bodies and other international regulatory agencies.
• Schedule, coordinate, and participate in Internal Audits of the Alydia Quality System.
• Manage the CAPA and Complaints systems.
• Manage the document control system.
• Manage training programs for the quality system.
• Develop and define quality metrics, analyze quality-related data and participate in periodic management review of the quality system.
• Support design control activities. Provide input to the engineering team on aspects of quality engineering (e.g. statistical methods, test method development, metrology).
• Maintain and revise Quality Agreements with contract manufacturer and suppliers.
• Primary contact with contract manufacturer quality assurance department. Audit contract manufacturer and suppliers for conformance with requirements.

Additional Responsibilities:
• Maintain professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, participating in professional societies.

Position Requirements:
• BS/BA or equivalent preferred.
• Scientific or engineering background preferred.
• Previous experience in Quality Assurance management preferably in the medical device field.
• 5+ years experience with FDA QMS regulations, ISO 13485, FDA submissions, international standards.
• Excellent organizational and communication skills.
• Ability to travel internationally and domestically.

Preferred Experience and Skills:
• 5+ years of progressive experience in a medical device quality assurance role, as well as working in a cross-functional environment.
• Experience participating in the development and maintenance of quality systems for small companies.
• Experience with contract manufacturers.
• Experience with EU MDR implementation.
• Experience with eQMS implementation.
• Certified Quality Auditor and/or Certified Quality Engineer.
• Excellent interpersonal, organizational, problem-solving, and written/verbal communication skills, confidence, and ability to work effectively with a wide variety of medical, research and administrative personnel within the company.
• Excellent teamwork skills with proven ability to cultivate collaboration within group and across multiple disciplines to ensure project success.
• Strong time-management skills.
• Professional interactions in office and with customers and vendors.
• Excellent documentation skills.
• Ability to multi-task and prioritize with flexibility required in a start-up environment.
• Able to balance working independently and within a team on a variety of projects.
• Proficient in MSWord/Excel/PowerPoint.