Quality System Manager

Austin, TX  (On-site)       ·      Full time

About the job

Please attach Cover Letter with Resume.

The Role

As the Quality System Manager, you will be responsible for managing the ongoing development, implementation, and maintenance of the Quality System at Paradromics. You will ensure the implementation of an effective Quality Management System that complies with applicable regulations (including 21 CFR 820) and standards, including design controls, risk management, receiving/inspection, manufacturing, and supplier quality processes and systems. This includes developing new processes and workflows that are customized to meet the needs of Paradromics through close collaboration with Hardware Engineering, Electrical Engineering, Software Development, Manufacturing, and the Quality department. You will manage the electronic Quality Management System (eQMS) and oversee document control activities, along with various tasks utilizing the Quality System as it is implemented and continuously improved. This role will work closely with the Quality Engineering and Regulatory Affairs teams, along with other departments across the company, to properly plan, scope, and prioritize the Quality System implementation. This position is instrumental in supporting the company’s continued growth and future success, and requires an individual with a “can-do,” self-starter attitude who is excited about working collaboratively and diving into hands-on, detailed quality work in an early-stage medical device company. This individual must be able to step back to view the bigger picture and understand where we are as a company to set priorities, strategy, and direction. This position is based on-site in Austin, Texas and will have less than 5% travel.

Responsibilities include:

• Implement the Quality System for Paradromics and oversee the eQMS development by functioning as the department primary eQMS administrator. This includes close collaboration with internal teams to ensure the processes and workflows meet internal stakeholder needs, and regular interactions with the eQMS vendor to manage the creation and roll-out of new Quality System elements.
• Development and maintenance of planning tools and documents to ensure the Quality System is implemented in accordance with company priorities and needs as Paradromics grows and expands operations.
• Maintain and continuously improve the Paradromics’ Quality Management System. This includes developing new processes for new activities that are planned, and creating the corresponding Quality System elements (SOP, WI, Forms, Records). These new processes and new activities will span all aspects of the business, with a focus on the design and development process, design controls, risk management, testing, receiving, inspection, manufacturing, supplier controls, and equipment. Building consensus amongst the process owners and transferring knowledge to process users is a key responsibility.
• Perform Document Control activities and other Quality activities/tasks that support product development, manufacturing, regulatory, and other departments as needed.
• Effectively communicate Quality requirements and needs to cross-functional teams and management.
• Be the point of contact for internal and external audits, including regulatory body audits and supplier audits.
• Ensure suppliers adhere to Paradromics’ Quality requirements. Oversee supplier quality activities including supplier qualification and evaluation.
• Support manufacturing by performing acceptance activities and Device History Record review.
• Support activities related to process events including Nonconformances, CAPAs, Complaints, SCARs, and audit findings.
• Participate in the development, delivery, and administration of quality training programs.

Required Qualifications

• Bachelor’s degree in an Engineering, Science or Technical field.
• 7+ years of Quality Systems experience in medical devices.
• Experience with Quality Systems in a start-up or small company environment.
• Strong knowledge of quality-related aspects of medical device development and manufacturing in the US, including Design Controls, Risk Management, CAPA/root-cause analysis, Verification & Validation (design & process), Complaint Handling, and Document Control.
• Experience auditing suppliers, including contract manufacturers.
• Advanced knowledge of medical device quality standards and regulations, including FDA QSR (21 CFR 820), ISO 13485, and ISO 14971.
• Experience supporting external audits (e.g., FDA, EU Notified Bodies, etc.).
• Able to develop creative solutions to complex problems that meet regulations and business needs.
• Able to work effectively in a team environment with a diverse group of people.
• Strong communication skills both orally and in written form with a clear and concise manner.
• Excellent organizational skills and the ability to deal independently with many issues at one time and prioritize accordingly.
• Proficient skills in statistical data analysis.
• Competent with Microsoft Office Suite, Google G-Suite and other PC based systems.
• Experience with eQMS and ERP software.

Preferred Qualifications

• Advanced degree(s) in Engineering or Science with research experience applicable to active implantable devices, neural implants, and/or brain-computer interfaces.
• Experience working directly in the brain-computer interface space or deep brain stimulation, neurostimulation, and/or neuromodulation.
• Experience with active electronic medical devices containing software.
• Certification(s) in a Quality-related discipline (e.g., CQE, 6 Sigma, Lean, etc.).
• Experience in auditing manufacturers of FDA Class III medical devices.
• Experience with Minitab (or similar statistical analysis software).

Paradromics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.

Please click here to apply.