Overview: Surgeon skill and experience are the biggest determinants of patient outcomes. Unfortunately, surgeons learn by operating on patients and sometimes they make costly mistakes. Lazarus 3D’s patented soft-3D printing technology allows physicians to rehearse every case before they operate so they can perfect their surgical plan. Lazarus 3D’s technology enables us to create copies of patients’ organs, directly from their MRI/CT data within 24 hours, using our proprietary soft-tissue 3D printing process.
In 2021, Lazarus 3D will obtain its Class II 510(k) FDA clearance for patient-specific surgical rehearsal models. We are currently seeking a highly motivated, driven Quality System Compliance Lead with the necessary experience to develop and implement an efficient, compliant, and effective eQMS for our new medical device. The Quality System Compliance Lead will have quality oversight over development, manufacturing, and other enabling processes for patient-specific surgical rehearsal models and will be responsible for all internal audits and external audit or inspection readiness for Lazarus 3D. This position is a unique opportunity to develop the quality processes and infrastructure required to deliver personalized surgical rehearsal products to the Healthcare industry so that development and manufacturing requirements are met under ISO13495 and the FDA, including but not limited to Operating Procedures, Work Instructions, Audit Plans, and External Audit Strategy.
The QS Compliance Lead plays a significant and strategic role in the success of Lazarus 3D and reports directly to the Chief Operating Officer.
About us: Lazarus 3D is a Medical Device Startup that has bootstrapped its rapid growth with limited resources and has the potential to become a multi-billion dollar pioneer in precision surgery. Our mission is to deliver solutions that solve the most fundamental challenges in healthcare today by providing a platform where surgeons can rehearse each individuals’ upcoming surgery ahead of time enabled by our core technology, the patient-specific preoperative surgical rehearsal (PRE-SURE) models. Personalized surgical rehearsals on individualized 3D replicas of patients can help improve patient education and communication, surgical planning and execution, patient-safety and surgical outcomes, as well as yield cost-savings to the $3.6Trillion US Healthcare burden.
Our Team: All of our full employees are located in Oregon. We plan on hiring the best person for the job, for every open position that we have. In our experience, that means hiring an extremely diverse workforce. Currently, a majority of our full time employees are women of color. Women of color also own a majority of the stock of our company. Our core founding team includes an Indian American female Ph.D. Scientist (the president of the company) and a Moroccan female biomedical engineer (our head of biomedical engineering). The whole team moved to Oregon because we love Oregon’s culture, and we expect to either recruit our new hires from the Northwest, or to bring in talented employees from across the country.
Job Description: We are looking for driven, communicative, hard-working people to be part of our community. The work we do is demanding, with requirements for rapid turn-around times, high precision, long hours (as required to meet deadlines) and novel, life-changing work. Since most of our work is custom, every day is different and all of our employees are driven, able to work with independence, curious, and flexible in how they can contribute. This is not a typical 9 to 5 job, and most people will not be able to make the cut. However, as a growing company if you succeed there are opportunities for extremely rapid advancement and equity in the company.
As a startup, if you are invited to join the Lazarus 3D team, you will almost certainly work harder and get paid less than other jobs, but you will have a chance to improve people’s lives, make a difference, learn a lot, and advance rapidly.
Assure that the company has policies, processes, and procedures in place so that internal audits and external audits are conducted and documented effectively and efficiently for the FDA and ISO13485.
Define and implement Quality System documentation, including procedures, work instructions, non-conformances, CAPA, and associated investigations for areas of responsibility.
Work closely with the Technical, Engineering, and Research & Development, Manufacturing, and other functions in order to ensure objectives are met in areas of responsibility.
Plan, schedule, manage, conduct, and report on internal audits of company and site processes and records to ensure compliance with applicable quality and regulatory standards.
Train, Coach, and Develop the team on a structural organization for QMS and compliance. Act as a lead auditor.
Act as an agent of change and continual improvement through audit conduct, and delivery of objective and impact-driven audit observations.
Lead external audit readiness activities to ensure preparedness for inspections by regulators and/or notified bodies. Develop roles, workflows, and training for audit participants and support personnel.
Perform regulatory intelligence activities to provide organizational foresight on changing regulations and inspection trends. Apply regulatory intelligence in audit plans and sampling strategies.
Perform compliance and/or gap assessments to regulations or standards for the purposes of planning improvement initiatives or change projects.
Participate in project work and initiatives associated with Quality System issues in conformance to regulatory requirements. Interface and provide Compliance guidance or training to functions. Participate in the design and implementation of quality improvement activities.
Maintain the metrics required to monitor the compliance of the internal audit program and escalate issues when necessary.
Implement an electronic QMS.
Support supplier audits as needed.
Help to drive management review.
Other tasks as required by the business.
We prefer applicants who:
Have experience working in a fast-paced start-up environment.
Have a minimum of 3+ years of relevant experience in leading QMS for regulations and standards affecting medical devices such as FDA QS Regulations Part 820 & Part 11, ISO13485, and cGMP required for maintaining validation and design control compliance.
Have led the development of medical device QMS systems.
Have expertise in designing SOPs.
Have expertise in performing and implementing quality control procedures.
Have strong written and verbal communication skills.
Have the ability to effectively manage short-term and long-term deadlines.
Have high standards for quality and attention to detail.
Work well in a collaborative environment.
Have a basic understanding of 3D printing.
We especially encourage women, minorities, and other disadvantaged groups to apply.
What we offer:
The opportunity for you to push yourself as far as you can, with significant and interesting problems to solve.
The opportunity to change people’s lives, literally.
An incredibly close, supportive environment forged by the difficulty of our job and the vision of how we can change the world.
A team of the best and brightest, where everyone accomplishes more than seems possible and supports each other in achieving our very high goals.
Opportunities for rapid advancement and career growth.
Flexible hours within project constraints.
Fun outdoor activities (Hiking, kayaking, rafting, camping, skiing and others)
Team Retreats, flexible PTOs, work/life balance, exceptional quality of life in the great North West.
Please apply with your CV and one-page cover letter detailing your interest in the company and relevant prior experiences (ideally in medicine, engineering, or entrepreneurship). CV should be titled in the following format: “CV_Laz3D_Firstname_LastName_2021”. A one-page cover letter is required.
As an additional step in the application process, selected applicants will be asked to do a pilot project to demonstrate their abilities before any hiring decisions are made. If hired, remuneration will be commensurate with experience and raises/advancement once joining the team will be based on accomplishments and overall company success.
Location: Corvallis, OR 97330 Position Type: Full-Time
Desired Degree(s): Bachelor’s degree in life sciences, engineering or business with 4+ years in quality assurance in a regulated industry; pharmaceutical, life sciences technology or medical device company.
Function: Development and Management of the Quality Management System and OPs, Medical Device FDA & ISO Compliance.
Why Apply? We are a fast growing startup and offer a wide range of internship opportunities. If you are a driven, highly motivated, and daring individual interested in Health-tech, 3D printing in medicine, and improving healthcare through innovative technologies, we encourage you to apply!
Work with us: Interns that are invited to join Lazarus 3D’s team are exposed to the fast-paced startup environment and gain first hand exposure to a multitude of tasks and responsibilities. Interns typically work under direct supervision and mentorship of a senior team member, and gain valuable knowledge and skills through their experiences. Through the initial rotation period, the intern is encouraged to identify what they are most passionate about and typically our team works towards enhancing their experience in those specialties.
Lazarus 3D is a strong advocate of diversity and inclusion, and we believe that diversity in our team is critical to our success and growth.
Requirements: We welcome all applicants and while we do not require expertise or specific backgrounds, we prefer applicants with some level of experience in STEM.