Director of Quality

Remote in San Diego       ·       Full time

Mainstay Medical

Mainstay Medical is a medical device company focused on marketing an innovative implantable neurostimulation system, ReActiv8®, for people with disabling chronic mechanical Low Back Pain. The company is headquartered in Dublin, Ireland, with subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.

The Role

Mainstay Medical is seeking a highly motivated Quality Director who will plan, manage and direct establishment of quality management system and maintain quality assurance standards.  The Quality Director is responsible for the application and maintenance of quality standards as they apply to products and services of the company both nationally and internationally.  Proactively communicate quality status to management. 

This is a strategic role with a blend of tactical activities.  Responsible for evolving the Quality function from supporting a start-up company to a commercial company as the company grows. Serves as the primary interface with FDA inspectors and Notified Body auditors during onsite inspections/audits. Responsible for managing the internal audit, CAPA, design quality, supplier quality and operations quality. Serves as the Quality interface with key contract manufacturers and suppliers. Works on complex issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objectives.  

Position Responsibilities

Quality Essentials

• Manage Change Control System for all controlled documents.
• Track, trend, & take action when necessary for supplier quality issues including initiating and management of Corrective and Preventative Actions (CAPA’s).
• Manage audits and support regulatory inspections of contract manufacturers, vendors and test labs; Including planning, scheduling and supporting audits to assure adherence to company quality policies and applicable regulatory requirements
• Guide Project teams ensuring that Design Control and product requirements are met and represent the Quality role during the Product Development process and Design Reviews.
• Provide Quality perspective on Design Verification/Validation study protocols and data analysis incorporating requirements or recommendations from applicable regulatory guidance’s and consensus standards.
• Verify documentation and design controls are appropriate for organization, including design history files (DHF), device master records (DMR), standard operating procedures (SOP), and change records
• Establish and implement company wide documentation procedures used in Good Manufacturing Practices including methods and procedures for development, testing and evaluation of components, subsystems, and finished products.  
• Establishes quality and reliability standards by studying product and consumer requirements with other members of management and with production operators, technicians, and engineers.
• Establishes in-process product inspection standards, product rework and dispositions standards by studying manufacturing methods, devising testing methods and procedures.
• Establishes product quality documentation system by writing and updating quality assurance procedures.
• Maintains product quality by enforcing quality assurance policies and procedures and government requirements; collaborating with other members of management to develop new product and engineering designs and manufacturing and training methods.
• Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends.
• Leads by example in complying with the policies, procedures and work instructions of Mainstay Medical and its subsidiaries.
• Ensure that accurate and complete records of department activities are kept, and that they meet regulatory requirements.
• Direct interactions with FDA, Notified Body, other agencies and vendors during company audits/inspections.  Lead the effort for attaining/maintaining third party certifications.
• Establish regular employee training in GMP and ISO regulations.  
• Thoroughly document all issues related to quality assurance, GMP, and ISO compliance.  
• Manage teams of quality personnel in achieving quality goals and objectives 

People Management Essentials

• Hire, train, and manage Quality staff.  Maintains quality system staff by recruiting, selecting, orienting, and training employees.  
• Maintains quality staff job results by coaching, counseling, and disciplining employees, planning, monitoring, and appraising job results.
• Completes quality assurance operational requirements by scheduling and assigning employees, following up on work results.
• Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
• Achieves financial objectives by preparing the quality assurance budget; scheduling expenditures; analyzing variances; initiating corrective actions.

Administrative

• Develop and administer department budgets, schedules, and other administrative functions. 
• Contributes to team effort by leading and accomplishing related results as needed 

Competencies

• Teamwork – ability to work with all functions within an organization.
• Integrity – handle confidential information in an effective manner. 
• Innovation – able to switch gears when the business requires it. 
• Leadership – ability to lead by example. Establish credibility within the organization and lead others when warranted. 

Qualifications

• BS/BA degree or advance degree related discipline is preferred.
• Minimum 10 years’ experience in a quality role within the medical device industry.
• Minimum 5 years of supervisory experience in a quality function within the medical device industry.
• Strong knowledge of 21CFRPart 820, ISO 13485:2016 and ISO 14971:2019.
• Certified ISO 13485:2016 Lead Auditor (preferred)

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle of feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel by car or airplane independently up to 20% of the time and work after hours is required by travel schedule or business issues. 

We hope you will join us on this journey to ReActiv8 life! 

• Dr. David Lee gives a quick presentation and perform our implant procedure on a synthetic cadaver. Feel free to watch our segment on Vimeo: https://vimeo.com/647859001/448fb6da23
• Watch video testimonial from Mainstay Medical patients: https://mainstaymedical.com/patients/#testimonials

Come join a growing and thriving organization!  We foster an exciting culture founded on teamwork, bias for action, urgency, and accountability, which allow us to develop meaningful and lasting relationships with our colleagues, the Doctors and Patients we serve.

We offer a competitive package.  Our core benefits include Medical, Dental, Vision, 401(k) Retirement Savings, Life and Short-Term Disability, PTO.

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