Analytical Laboratory Manager

Lead the Lab That Powers Life-Changing Innovation Behind every high-quality medical device is a laboratory that refuses to compromise on precision, compliance, and performance. We are seeking an Analytical Laboratory Manager to lead a critical function at the heart of a cutting‑edge medical device operation. In this role, you will drive laboratory excellence, ensure regulatory compliance, and guide a team responsible for product quality, validation, and investigation, making a direct impact on patient safety and innovation. Hours and Pay Schedule: Full‑time Location: On‑site Salary: Up to $137,000 annually (based on experience) Employment Type: Direct Hire Benefits This opportunity offers a comprehensive and competitive benefits package designed to support your health, financial wellness, and work‑life balance. Benefits include medical, dental, and vision insurance, along with pet insurance and a Health Savings Account (HSA). You'll also have access to a 401(k) retirement savings plan, Employee Assistance Program (EAP), commuter and parking benefits, AD&D insurance, and exclusive employee discount programs. This well‑rounded package ensures you and your family are supported both professionally and personally. What You’ll Do Lead daily analytical laboratory operations supporting incoming inspection, in‑process testing, final product release, validation, and complaint investigations. Ensure accuracy, timeliness, and compliance of all analytical testing aligned with regulatory and product requirements. Review and approve analytical data, reports, and test results prior to product disposition. Prioritize laboratory workload and allocate resources to meet production and quality demands. Ensure compliance with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and applicable ISO standards. Author, review, and maintain SOPs, test methods, validation protocols, and laboratory documentation. Maintain audit readiness and support FDA, notified body, and internal inspections. Lead investigations including OOS/OOT results, nonconformances, deviations, CAPAs, and change controls. Oversee development, validation, and lifecycle management of analytical methods. Ensure laboratory equipment is calibrated, qualified, and maintained; manage upgrades and new technology implementation. Lead, mentor, and develop laboratory personnel, ensuring training and competency standards are met. Drive continuous improvement initiatives to enhance efficiency, compliance, and cost‑effectiveness. Partner cross‑functionally with Manufacturing, Engineering, Quality, R&D, and Regulatory teams. What You Bring Bachelor’s degree in Chemistry, Analytical Chemistry, Materials Science, Engineering, or related field. 5‑7 years of analytical laboratory experience in a regulated medical device or life sciences environment. 2+ years of leadership experience (people or technical leadership). Strong knowledge of analytical techniques such as HPLC, GC, FTIR, UV‑Vis, and wet chemistry. Solid understanding of FDA QSR, ISO 13485, and medical device quality systems. Experience leading investigations, ensuring data integrity, and maintaining compliance. Preferred Qualifications Master’s degree in a scientific or engineering discipline. Experience supporting FDA or notified body audits. Familiarity with Laboratory Information Management Systems (LIMS). Six Sigma, Lean, or formal root cause analysis training. What Sets You Apart Proven leadership and team development skills. Strong analytical mindset with attention to detail and data integrity. Excellent communication and cross‑functional collaboration abilities. Ability to manage multiple priorities in a fast‑paced, regulated environment. Commitment to quality, compliance, and continuous improvement. This is a high‑impact leadership opportunity where your expertise will shape laboratory operations, ensure regulatory excellence, and contribute to the development of life‑changing medical technologies. Equal Opportunity Employer Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E‑Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at By applying, you consent to receive AI‑generated and non‑AI‑generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help. #J-18808-Ljbffr