About Alydia Health
Alydia Health is a venture backed, clinical stage medical device company developing technology to treat postpartum bleeding, change obstetric care and improve the mortality and morbidity associated with postpartum bleeding. As an early-stage medical device company we are dedicated to making childbirth safer for all mothers. Alydia has developed the Jada, an investigational device designed to rapidly stop abnormal bleeding following childbirth.
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 women’s healthcare and is motivated to do the hard and exciting work required to bring a ground-breaking technology to market.
Primary Function of Position:
The Senior Manager / Director Quality Assurance will help establish the direction for the development and administration of Alydia’s quality system. The Senior Manager / Director Quality Assurance will support cross-functional activites to assure compliance with quality system requirements.
The position has responsibility and authority for:
• Plan, direct or coordinate quality assurance programs and formulate quality control policies.
• Work closely with Regulatory Affairs to coordinate activity related to FDA and international filings, the European Authorized Representative, and other such areas that involve both Regulatory and Quality.
• 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 the training programs for the quality system.
• Develop and define quality metrics, analyze quality-related data and coordinate periodic management review of the quality system.
• Ability to travel internationally and domestically.
• Develop, maintain, and revise Quality Agreements with contract manufacturer and suppliers.
• Audit contract manufacturer and suppliers for conformance with requirements.
• Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
Level of Supervision Required:
Largely self-directed with low level of direct supervision needed to achieve goals.
• BS/BA or equivalent required; MBA or MS preferred. Scientific or engineering background preferred.
• 3-5 years of managerial experience, preferably in the medical device field.
• Previous experience in Quality Assurance management.
• 10+ years of experience with FDA QMS regulations, ISO 13485, FDA submissions, international standards.
• Excellent organizational and communication skills.
• 10+ years of progressive experience in a medical device quality assurance role, as well as working in a cross-functional environment.
• 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 and individual travel management skills.
• Strong organizational skill with attention to details.
• Professional interactions in office and with customers and vendors.
• Good documentation skills.
• Self-confident and able to react quickly under pressure.
• 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.
The physical demands described here are representative of those that must be met by the employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essentials functions of the role.
Light work positions involving sitting, standing, and walking. Position requires ability to frequently exert 10 pounds of force to move objects and occasionally exert up to 20 pounds of force to move objects.
Balance Crouching Kneeling Lifting Reaching Talking Standing
Feeling Hearing Grasping Fine motor skills Repetitive motion
This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position.
Employees will be required to follow any other job-related instructions and perform any other job-related duties required by the supervisor.
Alydia Health is an equal opportunity employer and does not discriminate in employment or hiring practices on the basis of race, sex, age, handicap, religion, national origin or any other basis prohibited by law.
All applicants should be legally entitled to work for any employer in the U.S.