Overview
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The Quality Manager is responsible for overseeing all aspects of quality, ensuring product integrity and compliance with company standards, industry regulations, and customer requirements. This role involves leading a team of quality professionals, maintaining a quality management system, and driving continuous improvement.
Responsibilities
- Be a role model for the company culture.
- Develop, implement, and management systems designed to ensure continuous production of products consistent with established standards, customer specifications, and production goals.
- Supervise and oversee the adaptation of new quality processes, standards, and specifications.
- Lead, manage, and develop the quality assurance team to achieve quality objectives.
- Provide coaching and training to quality assurance personnel on systems, policies, procedures, and core processes.
- Ensure compliance with national and international standards and legislation.
- Plan, conduct, and monitor testing and inspection of materials and products to ensure finished product quality.
- Coordinate and support on-site audits conducted by external providers or regulatory inspectors.
- Serve as Management Representative for ISO 13845 : 2016
- Analyze data to identify areas for improvement in the quality system.
- Develop, recommend, and monitor corrective and preventive actions.
- Prepare reports to communicate outcomes of quality activities to management.
- Interface with customers to understand their quality requirements and resolve quality issues.
- Ensure a high level of internal and external customer service by investigating and acting on customer complaints regarding quality.
- Promote quality achievement and performance improvement across the organization.
- Lead the team in identifying, planning, and implementing key projects to improve quality, reduce costs, and increase productivity.
- Perform tasks as required to help meet needs of business.
Requirements
Bachelor's degree in science, engineering or technical field, or equivalent experience.Minimum of 5 years of experience in quality assurance, quality control, or a related field, including at least 2 years in a managerial role.Working knowledge of FDA medical device regulations, guidance documents, international standardsExcellent communication skills, both verbal and written.Proficient in the use of MS Office and quality management software.Leadership and people management skills.Strong problem-solving and analytical skills.Detail-oriented with a methodical approach to work.Ability to manage multiple projects simultaneously and under tight deadlines.Strong organizational and follow-up skills.Physical Requirements
Regularly required to sit, stand, walk, climb, stoop and crouch, reach, grasp, feel, talk, and hear.Must be able to move around large areas.Must be able to lift, carry, or otherwise move objects unassisted.Required to lift more than 25 pounds occasionally and / or up to 50 pounds rarely.Required to see clearly at a distance of 20 inches or less.Must be able to judge distance and spatial relationships.Must be able to visually bring objects into sharp focus for reading machine dial gauges, blueprints, and precision measuring instruments used in the inspection of parts.This role may require occasional travel.Physical requirements include the ability to work in an office setting and visit production areas.
Seniorit y level
Mid-Senior levelEmployment type
Full-timeJob function
Information TechnologyIndustriesWireless Services, Telecommunications, and Communications Equipment ManufacturingReferrals increase your chances of interviewing at SIM Surgical by 2x
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