Job Description

Job Title: Quality Manager Job Description We are seeking an experienced Quality Manager to oversee and manage all activities related to our quality management system. The successful candidate will ensure compliance with FDA and ISO standards, manage internal and external audits, and lead initiatives to improve our quality processes. Responsibilities + Implement and maintain a quality system within FDA and ISO standards. + Serve as the Management Representative to the President/CEO for the quality management system, ensuring its effectiveness. + Assess and modify the quality management system to achieve compliance with relevant regulations. + Act as the external liaison for quality-related correspondence, meetings, and audits. + Oversee the Management Review process to inform management about the quality system status and identify improvement opportunities. + Coordinate the internal audit program and ensure corrective actions are implemented and effective. + Lead Root Cause and Corrective Action (RCCA) teams for failure analysis and recommend corrective actions. + Manage the Corrective Action and Preventive Action (CAPA) program. + Coordinate Material Review Board (MRB) to manage product disposition and guide corrective actions. + Investigate customer complaints and develop plans to address satisfaction issues. + Support quality inputs for new product development. + Coordinate calibration and recall systems for tools, gauges, and test equipment. + Validate and qualify equipment, products, and processes in collaboration with engineering and manufacturing. + Manage supplier evaluation and qualification system and perform supply chain quality audits. Essential Skills + Bachelor's degree or equivalent experience. + Minimum of five years of quality assurance/control management experience in a regulated environment. + Experience with practices such as SPC, FMEA, and process validation. + Quality engineering or manager certification (CQE or CQM) desirable. + At least three years in the medical device or related industry. Additional Skills & Qualifications + Working knowledge of shop math, plane/solid geometry, and trigonometry. + Ability to apply fractions, percentages, ratios, and proportions to quality situations. + Proficiency in reading, analyzing, and interpreting complex drawings and documents. + Strong communication skills for customer and senior management presentations. + Proficiency in Microsoft Office and general PC skills. Work Environment This position involves working in a regulated environment, ensuring compliance with FDA and ISO standards. The role requires collaboration with various departments, including engineering and manufacturing, and may involve some travel for supplier audits. The dress code is business casual, and the position typically follows standard working hours, with occasional requirements for flexibility based on project needs. Job Type & Location This is a Permanent position based out of Valencia, CA. Pay and Benefits The pay range for this position is $100000.00 - $120000.00/yr. see company benefits page at classic wire Workplace Type This is a fully onsite position in Valencia,CA. Application Deadline This position is anticipated to close on Dec 15, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

Job Tags

Permanent employment, Casual work, Work at office,

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