A DNA sequencing company transitioning from research use only into the clinical diagnostics arena needed an experienced QE to help lead and coach the R&D and Manufacturing groups on Quality requirements in an FDA regulated industry. They required a person with DNA sequencing instrumentation experience and the personality and ability to help the QA Director teach the rest of the company about operating in an FDA regulated environment.
In 6 weeks time we presented 5 possible candidates, all of which were interviewed. One of the candidates was equally strong in IVD instrumentation and taking reagents from development to manufacturing. Another candidate had the strong instrumentation experience they were looking for, and both had been in companies where training other departments in operating within an FDA regulated environment was needed. It was determined by our client that they would hire both of these candidates since they also had upcoming plans to hire someone to support the reagent manufacturing activities. As of this writing, both candidates have been with the company for over 3 years and feedback from the QA Director is that both have done great jobs for them.
Quality Director
A small, privately held medical device company needed a solid leader to help them prepare their Quality Systems to meet the new ISO standards and lead the efforts to get their CE Mark. This person needed the knowledge to lead these processes and also be willing to be hands on in doing the day-to-day Quality duties as well.
Within 5 weeks we located 4 possible candidates for consideration. Three of the 4 were interviewed and one was ultimately hired. Within the first year on the job our candidate was able to get the QMS updated to meet the new ISO standards and added to, and upgraded the Quality team to support the new requirements and help the company prepare for future growth and support clinical trials.
Principal Quality / Compliance Engineer
This clinical diagnostics company needed an experienced person that understood the diagnostics industry and requirements, as well as, the CLIA Lab requirements. They wanted someone that had worked for the FDA as well. We were able to find 2 that met their requirements and they hired both.
After looking nationwide for FDA or ex-FDA people (most of which had become high-priced consultants), we found 2 local people- one ex-FDA Consumer Safety Officer, and one currently working with the FDA office in San Francisco as a Quality Systems Manager. Our client interviewed both of these candidates and decided to hire both.
Contract Document Control Person
A client that designs and manufactures a very complicated capital equipment system needed some help for 6-9 months to help with their document control activities to help develop product development related documents, create templates and review documents for accuracy. This person needed to be able to work independently since they would be taking direction from the Document Control Lead located on the East Coast.
After a couple of weeks of searching we were able to find, screen, and present a candidate with a good background in Quality Training and Doc Control. This person had taken some time off of work to care for a new baby and was ready to get back to work. Our client interviewed her and saw other areas she could help with and decided to bring her on for a 6-month contract. Within the first 2 weeks the client saw the value of what she was able to do with document control, and also assigned them management of the Quality Training program. After 4 months on the contract, the client had expanded her role to include document control, training management, and supporting auditing. At the end of the 6 month contract our client decided to convert the contract employee to a direct hire employee and was promoted to QE/Technical Document Coordinator.
Senior Software Quality Engineer
This company of about 60 people was at a critical stage in their growth with a product that is an extremely complicated, heavily software dependent imaging and radiation therapy system. They were in the final stages of development and beginning to ramp up for commercialization of their system. They needed a very experienced Software QE to take a lead role on manual Black Box testing, developing requirements and creating test cases from those requirements for capital medical equipment.
We presented 3 candidates including one that had been a Manager previously with all of the experience they were looking for. The hiring manager easily selected this candidate saying their background looks like the job description was written with them in mind. This candidate was hired and quickly took the lead role on the project. Within 6 months this person was promoted to Software Quality Manager.
Senior Regulatory Affairs Specialist
Small medical device company needed a Regulatory Specialist as they conpleted their clinical studies and were preparing their submissions to the FDA for product clearance. The hiring manager oversaw both the Clinical and Regulatory activities for the company and needed someone that could really work independently on the Regulatory side while they focused on the critical Clinical studies.
We found a candidate at the Sr Specialist level but also asked the hiring manager if, given the fact they needed to focus on the Clinicals, would they consider a slightly higher level or a Principle Specialist. They agreed to look at Principle level candidates and we submitted 2 for consideration. Both were interviewed and one was hired that could take the lead role on the PMA submission project and also expressed interest in learning and helping on the Clinical side.
Director/Senior Director of Regulatory Affairs
This client is a very small (30 employees) biotech company that is developing a very unique product for the oncology market using CRISPR technology. They were at the very early stages of development and needed someone to help the company develop their regulatory strategy and guide them through the pre-IND stages and help them take their product through to final FDA approval. Ideally they were looking for someone with oncology product experience and had worked with the CBER division of the FDA. The company didn’t have an people with Regulatory experience and also needed someone that could educate the rest of the company (mainly Scientists that were new to the FDA regulated industry) on the requirements of development documentation. They were also using a consultant for Regulatory and Quality at this point.
Working directly with the hiring manager (CSO) of the company we established the critical things this person must be able to help them do in the first 12-18 months. It sounded like this might require a little more experience than a Director level person but they wanted to see some candidates first. We submitted 2 candidates at the Director level, but also submitted one at the Executive Director level. All candidates were interviewed by phone and it quickly became apparent that the higher level candidate would be needed. We submitted another candidate that had the oncolcoy and CBER experience the client was looking for, but was already an Executive Director. Both of these higher level candidates were deemed to be able to do the job and the hiring manager indicated the had the good problem of having 2 very qualified candidates to choose from. Ultimately the candidate that was hired also had Quality experience in more established companies and startups, and was brought on as the VP or Regulatory and Quality, further easing the burden on the CSO.
Quality Assurance Manager, Post Market Surveillance
A small Class III medical device company was preparing for commercial launch of their first product and needed to start building out their post market surveillance team. The hiring manager needed someone that could come in and improve and implement a complaint handling process, and eventually put this process in their electronic documentation system. There was a short timeframe to have it implemented and tested in time for their PMA approval, and commercial launch.
We were able to find 3 solid people for them to interview, and the client chose the person that had experience in smaller and larger organizations, giving them a good perspective on where the company was, and where they wanted to go. This person had also helped define and improve complaints systems, and had also mentored others to help grow the group. This person was able to streamline the process and brought some much-needed clarity to anyone participating in the complaints handling process. They also became a key person in the choosing and implementation of the eQMS to position the team and company for commercial launch.
