Senior Quality Engineering Manager, Combination Product Nearing FDA Clearance | 3663900

𝗥𝘂𝗻 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗼𝗻 𝗮 𝗰𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗽𝗿𝗼𝗱𝘂𝗰𝘁 𝘁𝗵𝗿𝗼𝘂𝗴𝗵 𝗙𝗗𝗔 𝗰𝗹𝗲𝗮𝗿𝗮𝗻𝗰𝗲 𝗮𝗻𝗱 𝗳𝗶𝗿𝘀𝘁 𝗰𝗼𝗺𝗺𝗲𝗿𝗰𝗶𝗮𝗹 𝗹𝗮𝘂𝗻𝗰𝗵, 𝗮𝘁 𝗮 𝗰𝗼𝗺𝗽𝗮𝗻𝘆 𝘀𝗺𝗮𝗹𝗹 𝗲𝗻𝗼𝘂𝗴𝗵 𝘁𝗵𝗮𝘁 𝘆𝗼𝘂𝗿 𝗷𝘂𝗱𝗴𝗺𝗲𝗻𝘁 𝘀𝗲𝘁𝘀 𝘁𝗵𝗲 𝗽𝗿𝗼𝗴𝗿𝗮𝗺.𝗪𝗵𝘆 𝘁𝗵𝗶𝘀 𝗿𝗼𝗹𝗲A build seat, not a maintenance seat. Our client is a small medical technology team taking a combination product through FDA clearance and into commercial manufacturing, and the quality program has to be ready before the product is. You set the priorities, run the quality system, and direct the outside validation firms that carry much of the equipment and process work, working directly with the executive team.𝗪𝗵𝗼 𝘁𝗵𝗿𝗶𝘃𝗲𝘀 𝗵𝗲𝗿𝗲• You are a senior quality engineering manager or quality manager ready to run quality for a whole program.• When there is more work than time, you decide what matters and can say what you chose not to do.• You tell leadership about a problem before anyone asks.• 𝗧𝗵𝗶𝘀 𝗶𝘀 𝗻𝗼𝘁 𝗳𝗼𝗿 𝘆𝗼𝘂 𝗶𝗳 you need a large team, a fully built system, or direction on each decision.𝗪𝗵𝗮𝘁 𝘆𝗼𝘂 𝘄𝗶𝗹𝗹 𝗼𝘄𝗻• The quality system day to day: CAPA, nonconformances, document control, training, supplier controls and audit readiness.• The validation program for equipment, processes and test methods, including the outside firms that execute much of it.• Quality engineering through scale-up and the first commercial builds, plus the risk files behind clearance and launch.• Straight, early reporting to leadership on where quality stands.𝗪𝗵𝗮𝘁 𝘆𝗼𝘂 𝗯𝗿𝗶𝗻𝗴• Ten or more years in medical device or combination product quality in manufacturing, including time leading quality engineers.• IQ, OQ, PQ and process validation you have written and run yourself, not only approved.• ISO 13485 and FDA's quality system regulation in practice, including FDA inspections or notified body audits.• Experience directing contractors or an outside validation firm, and a degree in engineering or science.• A plus: combination product experience, sterilization validation, or ISO 13485 lead auditor certification.𝗣𝗮𝘆 𝗮𝗻𝗱 𝗯𝗲𝗻𝗲𝗳𝗶𝘁𝘀Base salary of $150,000 to $180,000, plus bonus and equity eligibility. Platinum PPO medical with no in-network deductible, dental, vision, a 401(k) match that vests immediately, and 15 vacation days plus 10 holidays to start. Relocation assistance is available.𝗛𝗼𝘄 𝘁𝗼 𝗮𝗽𝗽𝗹𝘆Apply right here on Linked In with your resume. That is all we need to get started, and we will contact you directly.𝗣𝗮𝘃𝗲 𝗧𝗮𝗹𝗲𝗻𝘁 | 𝗛𝗶𝗿𝗶𝗻𝗴 𝗥𝗲𝗶𝗺𝗮𝗴𝗶𝗻𝗲𝗱Pave 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.