21 Quality Systems Specialist Jobs in Cleveland, OH
LHH is Hiring a Quality Systems Specialist Near Cleveland, OH
Responsibilities:
- Maintain the Quality Management System in accordance with regulatory requirements (e.g., FDA QSR, ISO 13485). Ensure that processes are documented, controlled, and effectively communicated throughout the organization.
- Regulatory Compliance: Stay abreast of relevant regulations and standards governing medical device manufacturing and ensure compliance with all applicable requirements. Assist in regulatory submissions and provide support during audits and inspections by regulatory authorities.
- Conduct internal audits to assess compliance with quality system procedures and regulatory requirements. Identify areas for improvement and collaborate with cross-functional teams to implement corrective and preventive actions.
- Manage the document control system, including document creation, review, approval, distribution, and maintenance. Ensure that all documents are controlled, up-to-date, and accessible to authorized personnel.
- Develop and deliver training programs on quality system procedures, regulatory requirements, and quality-related topics. Ensure that all employees are adequately trained to perform their roles effectively and in compliance with quality standards.
- Collaborate with the purchasing department to evaluate and qualify suppliers. Monitor supplier performance through audits, assessments, and ongoing communication. Address supplier non-conformances and drive continuous improvement initiatives.
- Lead or support Corrective and Preventive Action (CAPA) activities, including investigation, root cause analysis, corrective action implementation, and effectiveness verification. Ensure timely closure of CAPAs and documentation of outcomes.
- Facilitate risk management activities, including risk assessment, mitigation planning, and risk monitoring throughout the product lifecycle. Ensure that risk management processes are integrated into product development and manufacturing processes.
- Bachelor's degree in a relevant field (e.g., Quality Assurance, Engineering, Life Sciences) or equivalent experience.
- OTC Medical device,requlatory experience.
- Previous experience in a quality-related role within the medical device industry, with a strong understanding of quality management principles, regulations, and standards.
- Experience with quality system requirements, such as document control, internal auditing, CAPA management, and risk management.
- FDA regulations (e.g., 21 CFR Part 820), ISO 13485, and other relevant quality standards required.
- Excellent communication, organizational, and problem-solving skills. Ability to work effectively in a cross-functional team environment.
- Attention to detail and ability to prioritize tasks in a fast-paced manufacturing environment.
- Proficiency in Microsoft Office applications and experience with electronic quality management systems (eQMS) is required.
Search managed by: Sandie Johnson
Equal Opportunity Employer/Veterans/Disabled
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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.
Job Summary
Full Time
Hospital
$84k-103k (estimate)
06/23/2024
07/18/2024
lenoxhill.northwell.edu
NEW YORK, NY
1,000 - 3,000
Private
FRANCK DANZA
$1B - $3B
Hospital
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The job skills required for Quality Systems Specialist include Problem Solving, Microsoft Office, Quality Assurance, Attention to Detail, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Systems Specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Systems Specialist. Select any job title you are interested in and start to search job requirements.
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Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Quality Systems Specialist job description and responsibilities
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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Quality Systems Specialist jobs
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