Senior Quality Manager, Medical Device Combination Product, Validation to Launch | [3699766]

𝗢𝘄𝗻 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗳𝗼𝗿 𝗮 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 𝗵𝗲𝗮𝗱𝗶𝗻𝗴 𝗳𝗿𝗼𝗺 𝗙𝗗𝗔 𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻 𝘁𝗼 𝗶𝘁𝘀 𝗳𝗶𝗿𝘀𝘁 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀, 𝗮𝘁 𝗮 𝗰𝗼𝗺𝗽𝗮𝗻𝘆 𝘀𝗺𝗮𝗹𝗹 𝗲𝗻𝗼𝘂𝗴𝗵 𝘁𝗵𝗮𝘁 𝘆𝗼𝘂𝗿 𝗰𝗮𝗹𝗹𝘀 𝗮𝗰𝘁𝘂𝗮𝗹𝗹𝘆 𝘀𝗵𝗶𝗽. This is the quality leadership seat for a hands-on Quality Manager or Senior Quality Manager who wants to build validation, process control, and product release from the ground up, with a clear path to director. 𝗧𝗛𝗘 𝗖𝗢𝗠𝗣𝗔𝗡𝗬 Pave Talent is hiring on behalf of our client, a small, commercial-stage medical technology company with a marketed Class II product and a working quality system already in place. Their next product, a device with combination-product elements, is headed for a 510(k) (FDA premarket notification) submission at year-end, with clearance expected in mid-2027. It is manufactured in-house at the same site where you will work, and leadership expects revenue to grow more than tenfold within about 18 months of launch. 𝗪𝗵𝗼 𝘁𝗵𝗿𝗶𝘃𝗲𝘀 𝗵𝗲𝗿𝗲 Builders who want to stand up validation, process qualification, and product release, not coast in a steady-state system Leaders who still like doing the work themselves and pitch in when something is stuck, even when it is technically someone else's task People who know when to dig deep on a high-risk item and when to sign off fast and keep work moving Quality professionals with recent time at a smaller company (under about 100 people) who know what that means day to day People who want to be onsite with the team and on the manufacturing floor every day If you are hoping to build a big department, lean on consultants to make quality decisions, or work remotely part of the week, this is not your role. 𝗧𝗛𝗘 𝗢𝗣𝗣𝗢𝗥𝗧𝗨𝗡𝗜𝗧𝗬 You will have overall responsibility for quality, reporting to senior leadership and partnering daily with Operations and R&D. You will work alongside an experienced quality systems manager, with a quality engineer hire planned. The next eight months are the build: validation, process qualification, and getting ready to release product to patients. Consultants add capacity for volume work, but you direct them and check their output. As the hiring manager put it: "They cannot hand over the keys. They're going to have to be in charge." 𝗪𝗛𝗔𝗧 𝗬𝗢𝗨'𝗟𝗟 𝗢𝗪𝗡 Validation and process qualification, including installation, operational, and performance qualification (IQ/OQ/PQ), for a product heading to launch The product release process, built from scratch so product can safely reach patients Quality oversight of in-house manufacturing, raw-material and other external suppliers, and outside release-testing labs Change control, nonconformances, deviations, and corrective and preventive actions (CAPA), with risk-based judgment on how deep each one goes Design history file and launch-readiness work alongside R&D and Regulatory Internal and external audits, plus direction of the outside auditors and consultants you bring in Decisions on when to add people, as the product scales and demand grows 𝗧𝗛𝗘 𝗥𝗘𝗔𝗟 𝗧𝗔𝗟𝗞 This is a small team in a pivotal year, and you will work at both levels: setting direction one hour, writing a protocol the next. In the hiring manager's words: "This is not a steady state kind of coasting type deal. This is for someone who wants to be building." The team grows only as the product demands it, never for its own sake. 𝗪𝗛𝗘𝗥𝗘 𝗜𝗧 𝗚𝗢𝗘𝗦 As revenue scales, so does the function and your scope: possible insourcing of release testing, new variants, improvement projects, and eventually markets outside the US. Leadership is open to this becoming your first director-level role. They are looking for someone who still wants to prove themselves. 𝗪𝗛𝗔𝗧 𝗬𝗢𝗨 𝗕𝗥𝗜𝗡𝗚 𝗥𝗲𝗾𝘂𝗶𝗿𝗲𝗱: Bachelor's degree in engineering, science, or a related technical field 8+ years in quality in medical devices, pharmaceuticals, or another FDA-regulated industry, including time leading quality work or people Hands-on process validation, process qualification, and product release experience Working knowledge of the FDA Quality Management System Regulation (QMSR) and ISO 13485, plus audit experience Recent experience (roughly the last five to ten years) at a company under about 100 people; a strong preference from leadership 𝗕𝗼𝗻𝘂𝘀 𝗣𝗼𝗶𝗻𝘁𝘀: Combination product experience (device plus drug) A product taken through 510(k) clearance and commercial launch Supplier quality and consultant management experience 𝗖𝗢𝗠𝗣𝗘𝗡𝗦𝗔𝗧𝗜𝗢𝗡 𝗔𝗡𝗗 𝗗𝗘𝗧𝗔𝗜𝗟𝗦 𝗕𝗮𝘀𝗲 𝗦𝗮𝗹𝗮𝗿𝘆: $130K to $180K 𝗕𝗼𝗻𝘂𝘀 Eligible Equity in the form of stock options 𝗦𝗰𝗵𝗲𝗱𝘂𝗹𝗲: Full-time, onsite five days a week at the manufacturing site 𝗥𝗲𝗹𝗼𝗰𝗮𝘁𝗶𝗼𝗻: Candidates willing to relocate are welcome Apply right here on LinkedIn with your resume and we'll reach out to schedule a conversation. Your application is fully private. 𝗣𝗮𝘃𝗲 𝗧𝗮𝗹𝗲𝗻𝘁 | 𝗛𝗶𝗿𝗶𝗻𝗴 𝗥𝗲𝗶𝗺𝗮𝗴𝗶𝗻𝗲𝗱 Pave Talent and our client are equal opportunity employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable law.