Quality Systems Specialist
Cleveland, Ohio
Direct Hire
$62,000.00 - $70,000.00 per Year
Quality Specialist- Cleveland, OH area
LHH Recruitment Solutions is hiring a Quality Specialist for a medical device manufacturing company in Cleveland, OH area. This role involves ensuring that products meet regulatory standards and internal quality requirements. If you have worked in Quality for 2+ years with FDA Regulations for a OTC medical device manufacture and are looking for a growing organization that values their team members APPLY TODAY!
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.
Qualifications:
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.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.lhh.com/us/en/candidate-privacy
The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.
Quality Systems Specialist
LHH
28 days ago
$62,000.00 - $70,000.00 per Year
Direct Hire
Cleveland, Ohio
Quality Specialist- Cleveland, OH area
LHH Recruitment Solutions is hiring a Quality Specialist for a medical device manufacturing company in Cleveland, OH area. This role involves ensuring that products meet regulatory standards and internal quality requirements. If you have worked in Quality for 2+ years with FDA Regulations for a OTC medical device manufacture and are looking for a growing organization that values their team members APPLY TODAY!
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.
Qualifications:
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.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.lhh.com/us/en/candidate-privacy
The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.