Sr. Quality Assurance Manager

Renovo Solutions is a nationwide healthcare technology management company. We offer a range of opportunities for technicians to grow within the company. With a presence in 40+ states, we provide comprehensive solutions for managing & maintaining healthcare technologies. We prioritize investing in our employees' development, offering various phases and advancement paths. Through ongoing training, mentorship programs, and a supportive work environment, we foster professional growth and promote from within. Join our team to make a difference in healthcare while advancing your career with Renovo.Summary:The Life Science Quality Assurance Manager, reporting to the Director of Healthcare Technology Management & Quality Assurance, will be primarily responsible for establishing, implementing, and maintaining the processes required for the Quality Management System (QMS) in accordance with ISO 9001:2015, ISO/IEC 17025:2017, 21 CFR Part 11, and 21 CFR Part 210/211.What you will do:Continuously assess, manage, and improve Life Science organizational processes within GxP/GMP environments to drive operational efficiency, productivity, and growth, ensuring full compliance with contractual and regulatory requirements.Lead initiatives to ensure compliance, manage QMS tools, and champion a culture of continuous improvement across all levels of the organization in LS.Develop, maintain, and continuously update documentation for ISO/IEC 17025:2017 and GxP/GMP compliance, including policies, procedures, forms, and records, ensuring all materials reflect current standards and practices.Collaborate with Life Science teams to develop, implement, and maintain robust training programs aimed at fostering continuous improvement and skills development within the process development team.Conduct regular internal audits to ensure ongoing regulatory compliance and actively support external audit activities related to ISO 9001:2015 certification and ISO/IEC 17025:2017 accreditation.Identify nonconformities, implement corrective actions, and track progress to ensure timely resolution and prevent recurrence.Qualifications:Thorough understanding and practical experience with ISO/IEC 17025:2017, including implementing and maintaining the standard within a laboratory setting.Proven experience (minimum experience of 7 years) in quality management, preferably in a testing or calibration laboratory, with a focus on compliance, audits, and process improvement.Strong verbal and written communication skills, essential for effective interaction with laboratory personnel, accreditation bodies, and other key stakeholders.Meticulous attention to detail to ensure compliance with ISO/IEC 17025:2017 and GxP/GMP requirements and to identify opportunities for continuous improvement.Proficient in data analysis, root cause analysis, and implementing corrective and preventive actions to enhance quality and compliance.Professional experience in the pharmaceutical industry, including quality assurance, pharmaceutical production, and quality control within a GMP-regulated environment.Strong teamwork, collaboration skills, and effective stakeholder management to drive alignment and ensure successful outcomes.Highly detail-oriented, accurate, impartial, and conscientious in working methods.Education/Special Training:Bachelor’s degree in Life Sciences, Engineering, Quality Management, or a related field (Master’s preferred).GMP (Good Manufacturing Practice) training, with emphasis on equipment maintenance, calibration, and validation within regulated industries.Certification in Quality Management Systems (QMS) or relevant industry certifications (e.g., Certified Quality Auditor or Certified Quality Engineer).Familiarity with regulatory requirements (FDA, EMA) for the pharmaceutical industry and healthcare-related equipment.Training in project management or relevant experience managing cross-functional teams.Safety Requirements:Abide and follow our Injury & Illness Prevention Program.Maintains a safe working environment for self and others in accordance with the facility’s policies.Must follow OSHA guidelines regarding blood-borne pathogens, airborne pathogens, radiation, sharp instruments and/or tools, hazardous liquids, and operating devices.On-time completion of safety training assignments.Physical Requirements:The Quality Assurance Manager, Life Science must be able to speak, hear, see, read, write, type, dial, reach, and bend.Must have near vision, far vision, depth perception, and be able to distinguish colors.Must have sensory ability to distinguish hot, cold, range of temperatures, surfaces, fine motor skills, manual dexterity, and detect/distinguish odors.Classification:

FLSA: ExemptTravel Requirements:Travel will be required for this position including airline travel and overnight stays.

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