Quality Manager
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Sterile Processing Technician
Sterile Processing Technician
Sterile Processing Technician
Sterile Processing Technician
Sterile Processing Technician
Cleveland, OH
$90-110K/year
Quality Manager will evaluate the quality assurance of processes and products, and to recommend revisions of indicated specifications, while serving as a liaison between engineering, safety, production teams, and customers. Responsibilities include the testing of products, systems, and procedures to ensure that technical standards are met and documenting both the findings and conclusions of those findings.
Quality Manager Responsibilities:
- Assures that engineering and manufacturing processes are performed correctly, using the right tools, materials, and processes.
- Designing the company’s quality standards and testing processes against those criteria.
- Implements inspection plans for new projects and updates current projects as necessary.
- Supports manufacturing engineer in process validations, process control, process training programs, process improvement, risk management, and software validations and control.
- Develops protocols for validation, evaluates data, and writes reports.
- Be responsible for the new testing equipment and new test methods development – MSA, GR&R included.
- Collaborates with Process Engineer on PFMEA development and revisions.
- Collaborate with Material Engineer, Quality Manager and R&D Team on Control Plans development or revision.
- Be the voice of Quality and collaborate with Product Manager.
- Lead Continuous Improvement efforts, problem identification, improvement, and resolution.
- Prepares reports to evaluate effectiveness of quality systems.
- Provides support to Quality Team and customer representatives in regards to quality issues resolutions.
- Works with suppliers to resolve or improve quality issues and to implement effective corrective action.
- Develops and maintains quality standards and requirements for development and design projects.
- Ensure products adhere to company and industry standards.
- Works cooperatively in a team environment to reach common results and goals.
Quality Manager Requirements:
- Bachelor’s Degree in Chemistry, Engineering, or related discipline; graduate degree preferred (MS or MBA) or combination of education & experience.
- 6+ years of progressive quality experience in manufacturing environments
- Prior Root Cause Analysis (RCA) Experience required
- Knowledge of Quality Management Concepts like GR&R, MSA studies, Calibrations, MOC, KPI, Continuous Improvement, 5S, etc…
- Knowledge of and experience with ISO 9001-2015 and IATF 16949-2016 requirements
- Strong work ethics and bias for adhering to standards
- Self-motivate and with the initiative to complete task
- Ability to work independently and in teams with infrequent supervision and reviewing
- Excellent interpersonal and team-player skills
- High attention to details and strong organizational skills
- Good analytical, critical thinking and problem-solving skills and ability to conduct root cause analysis and devise suitable preventive actions plans
- Past success in technical troubleshooting
- This position serves as a springboard for growth and development opportunities within the Quality department of the organization