{"id":3901484,"url":"https://alion.io/job/mesa-labs-manager-qa-regulatory-affairs","title":"Manager, QA & Regulatory Affairs","company":{"id":2800669,"name":"Mesa Labs","domain":"mesalabs.com","url":"https://alion.io/company/mesalabs","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"UltiPro","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["San Diego, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":119000,"max":148875,"currency":"USD","period":"year","gross":null,"usd_annual":148875},"salary_estimate":null,"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-10-29T15:57:30Z","employer_posted_date":"2026-10-29","last_verified_at":"2026-11-13T04:12:46Z","board_verified":true,"closed_at":null,"days_open":14,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":14},"description":"Are you looking for an opportunity to make a difference? At Mesa Labs we’re passionate about protecting the vulnerable by enabling scientific breakthroughs, ensuring product integrity, increasing patient and worker safety, and improving quality of life around the world.\nAt Mesa Labs we offer competitive wages, including potential bonus opportunities, equity awards, commission, and a comprehensive benefits package based on the position.\nBase Compensation Range: $119,000 - $148,875/yr\n*In addition, you qualify for:\nAnnual bonus opportunity of 15% based on company performance\nAnnual equity award of $14,000\nOutstanding Benefits and Perks\n We are proud to offer a variety of benefits that meet the diverse needs of our employees:\nEligible for benefits the first day of the month after you start\nTiered Medical, Dental and Vision Insurance options, Health savings (HSA), healthcare & dependent care flexible spending (FSA) accounts\nCompany paid short term and long-term disability (unless covered by a state disability plan)\nCompany paid life insurance and AD&D\nFlexible Time Off Policy\nPaid sick leave of 48 hours per calendar year\nEligible employees may receive four (4) weeks paid Care Giver leave after 1 year of service or in accordance with state leave laws\n401(k) plan that provides a 4% Safe Harbor company match on a 4% employee contribution that begins on Day 1\nEmployee Wellness and Financial Assistance Resources through Cigna and NY Life\nNine (9) paid company holidays per year\nAgena Bioscience® empowers research laboratories worldwide to deliver scalable targeted genomic data. Our open, advanced platform, the MassARRAY® System, provides researchers with insights through a highly multiplexed solution in the areas of mutation profiling, liquid biopsy, pharmacogenetics, and more.\nJob Summary\nThe Manager, Quality Assurance & Regulatory Affairs is responsible for managing day-to-day Quality Assurance and Regulatory Affairs activities to support product quality, regulatory compliance, and effective execution of the Quality Management System (QMS). This role leads a team of quality and/or regulatory professionals, translates department priorities into operational plans, and ensures assigned quality and regulatory programs are executed consistently and effectively. The Manager partners with Engineering, Operations, Supply Chain, R&D, Commercial, and other functions to resolve quality and compliance issues, support product lifecycle activities, and drive continuous improvement.\nDuties/Responsibilities\nQuality Management Systems & OperationsManage the implementation, maintenance, and ongoing effectiveness of assigned elements of the Quality Management System in accordance with applicable standards, regulations, and company requirements.\nTranslate quality objectives and department priorities into team goals, work plans, and measurable activities.\nMonitor quality metrics and trends, identify issues, and implement appropriate actions to improve performance.\nPartner with cross-functional teams to ensure quality requirements are incorporated into product lifecycle and operational activities.\n\nRegulatory Affairs SupportManage assigned regulatory activities supporting product development, market access, product changes, and lifecycle management.\nEnsure regulatory activities are completed in accordance with applicable global requirements, standards, and internal procedures.\nCoordinate regulatory submissions, change notifications, registrations, and communications with regulatory bodies as applicable.\nAssess regulatory requirements and provide guidance to cross-functional partners on routine and moderately complex regulatory matters.\n\nLeadership & People ManagementLead, coach, and develop Quality Assurance and/or Regulatory Affairs employees, establishing clear priorities, expectations, and accountability.\nAssign work, monitor progress, and balance team resources to meet operational and project requirements.\nConduct performance discussions, support employee development, and address performance concerns in partnership with Human Resources as appropriate.\nBuild team capability through coaching, knowledge sharing, and development opportunities.\nFoster a culture of quality, compliance, collaboration, and continuous improvement.\n\nCompliance, Audits & Risk ManagementMaintain audit and inspection readiness for assigned areas and support internal and external audits, inspections, and regulatory assessments.\nCoordinate responses to audit observations, nonconformances, and regulatory findings, ensuring actions are completed accurately and on time.\nIdentify quality and compliance risks within assigned areas and escalate significant issues as appropriate.\nSupport implementation of risk mitigation activities and monitor effectiveness.\n\nCorrective & Preventive Action (CAPA)Manage or support root cause investigations and corrective and preventive action activities for quality and compliance issues.\nEnsure investigations are appropriately documented, actions address identified causes, and commitments are completed within required timelines.\nMonitor CAPA effectiveness and identify recurring issues or trends requiring additional action.\nPartner with cross-functional teams to improve product and process quality and prevent recurrence of quality issues.\n\nCross-Functional CollaborationPartner with Engineering, Operations, Supply Chain, R&D, Commercial, and other functions to resolve quality and regulatory issues and support business objectives.\nProvide practical quality and regulatory guidance for new and existing products, processes, and operational changes.\nParticipate in cross-functional projects and ensure quality and regulatory requirements are understood and incorporated into project plans.\nCommunicate significant quality, compliance, and regulatory issues to appropriate stakeholders and management.\n\nContinuous Improvement & Operational ExcellenceLead or support improvement initiatives within assigned quality and regulatory processes using data and established continuous improvement methods.\nIdentify opportunities to improve efficiency, consistency, documentation, and compliance.\nImplement standardized processes and tools that improve team effectiveness and scalability.\nPromote continuous improvement and problem-solving within the team.\n\nReporting & CommunicationPrepare and communicate quality and regulatory metrics, trends, risks, and program status to management and cross-functional stakeholders.\nAnalyze data to identify trends, support decisions, and recommend actions within assigned areas.\nMaintain clear and timely communication regarding quality events, regulatory activities, project status, and emerging risks.\n\nExperience/Education\nBachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related discipline, or equivalent combination of education and experience.\nTypically 6-8 years of progressive experience in Quality Assurance and/or Regulatory Affairs within a regulated environment.\nTypically 2-3 years of people leadership, supervisory, team lead, or other demonstrated leadership experience.\nExperience working with cross-functional teams and managing multiple quality or regulatory priorities.\nKnowledge and Skillsets Required\nStrong working knowledge of Quality Management Systems and applicable regulatory compliance frameworks.\nExperience with audits, CAPA, nonconformance management, change control, risk management, and related quality processes.\nWorking knowledge of regulatory requirements and product lifecycle activities applicable to the business.\nDemonstrated people leadership skills, including coaching, performance management, prioritization, and team development.\nStrong analytical, problem-solving, and decision-making skills with the ability to resolve moderately complex issues and escalate higher-risk matters appropriately.\nStrong communication and influencing skills with the ability to collaborate effectively across functions and organizational levels.\nAbility to translate department objectives into operational plans, priorities, and measurable team results.\nStrong organizational and project management skills with the ability to manage competing priorities and deadlines.\nPhysical Demands:\nSitting: Often for extended periods at desks or meetings.\nStanding or walking: Occasionally for meetings, audits, inspections, or office tasks.\nUsing computers: Typing and using office equipment.\nLifting: Light, less than 10 pounds.\nRepetitive motions: Frequent use of keyboard and mouse.\nEnvironmental Conditions:\nWorkspace: Climate control (air conditioning or heating) to ensure comfort.\nLighting: Adjustable lighting to reduce eye strain.\nNoise Levels: The noise level is moderate, with occasional interruptions from phone calls and conversations. Use non-canceling headphones if necessary.\nErgonomics: Workstations with desk and adjustable chairs to support good postures.\nVentilation: Good ventilation to ensure a comfortable working environment, though this can vary depending on the building.\nMesa Labs is an Equal Employment Opportunity Employer.\nMesa Labs prohibits unlawful discrimination and harassment against applicants or employees based on age, race, sex, color, religion, creed, national origin or ancestry, disability, military status, sexual orientation, or any other status protected by applicable state or local law. 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