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.

Click Apply Now to take the next step in your leadership career.

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