Final Quality Inspector
Johnson Service Group
Johnson Service Group is seeking a Quality Inspector for a contract role that can convert full-time based on performance. Our client is at the forefront of precision engineering and innovation specializing in the development and manufacturing of vital components for medical markets.
Payrate: Up to $27 per hour based on experience Day Shift: The day shift can start at 8-4:40 or 7:30 - 4:10,
The Final QC Inspector will be responsible for ensuring the accuracy, completeness, and compliance of lot history records in alignment with company procedures and applicable quality standards. The ideal candidate will have a strong understanding of manufacturing and documentation processes and practices, with a focus on maintaining thorough and organized records throughout the production lifecycle.
Responsibilities:
Review and verify the completeness and accuracy of Lot History Records (LHRs) for products manufactured in accordance with established procedures and specifications. Ensure that LHRs contain all required documentation, including production records, inspection records, test results, certificates of conformance, and other relevant information. Verify that production activities documented in LHRs are consistent with approved manufacturing processes, work instructions, and quality control plans. Conduct detailed reviews of manufacturing and inspection documentation to identify discrepancies, deviations, or non-conformities and initiate appropriate containment, feedback, corrections and corrective actions. Collaborate with manufacturing, engineering, planning and quality assurance teams to address discrepancies, resolve issues, and ensure timely closure of LHR review findings. Maintain organized and up-to-date records of LHR reviews, findings, and corrective actions to support compliance with regulatory requirements and audits. Assist in the development and implementation of procedures, work instructions, and training materials related to LHR documentation and review processes. Participate in internal audits and external inspections to demonstrate compliance with regulatory requirements, quality standards, and best practices for LHR review. Stay current with changes in regulatory requirements, industry standards, and best practices related to DHR documentation and quality management systems in the medical device industry. Provide guidance and support to production personnel on proper documentation practices, recordkeeping requirements, and adherence to quality system procedures.
Requirements / Skills:
Associate or bachelor’s degree in engineering or science preferred. Minimum of 2-3 years of experience in quality assurance or regulatory affairs roles within the medical device industry, with specific experience in DHR review and documentation. Strong understanding of medical device manufacturing processes, Good Manufacturing Practices (GMP), and quality system regulations (e.g., 21 CFR Part 820, ISO 13485 and/or ISO9001). Knowledge of document control principles and practices, including version control, change management, and record retention requirements. Excellent attention to detail and organizational skills, with the ability to systematically review and analyze complex documentation for accuracy and completeness. Effective communication and interpersonal skills, with the ability to collaborate with cross-functional teams and communicate findings and recommendations clearly and concisely. Proficiency in Microsoft Office applications (e.g., Word, Excel, PowerPoint) and document management systems used for electronic recordkeeping. Ability to work independently with minimal supervision, manage multiple priorities, and meet deadlines in a fast-paced and dynamic environment. JSG offers medical, dental, vision, life insurance options, short-term disability, 401(k), weekly pay, and more. Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.
#D800
Payrate: Up to $27 per hour based on experience Day Shift: The day shift can start at 8-4:40 or 7:30 - 4:10,
The Final QC Inspector will be responsible for ensuring the accuracy, completeness, and compliance of lot history records in alignment with company procedures and applicable quality standards. The ideal candidate will have a strong understanding of manufacturing and documentation processes and practices, with a focus on maintaining thorough and organized records throughout the production lifecycle.
Responsibilities:
Review and verify the completeness and accuracy of Lot History Records (LHRs) for products manufactured in accordance with established procedures and specifications. Ensure that LHRs contain all required documentation, including production records, inspection records, test results, certificates of conformance, and other relevant information. Verify that production activities documented in LHRs are consistent with approved manufacturing processes, work instructions, and quality control plans. Conduct detailed reviews of manufacturing and inspection documentation to identify discrepancies, deviations, or non-conformities and initiate appropriate containment, feedback, corrections and corrective actions. Collaborate with manufacturing, engineering, planning and quality assurance teams to address discrepancies, resolve issues, and ensure timely closure of LHR review findings. Maintain organized and up-to-date records of LHR reviews, findings, and corrective actions to support compliance with regulatory requirements and audits. Assist in the development and implementation of procedures, work instructions, and training materials related to LHR documentation and review processes. Participate in internal audits and external inspections to demonstrate compliance with regulatory requirements, quality standards, and best practices for LHR review. Stay current with changes in regulatory requirements, industry standards, and best practices related to DHR documentation and quality management systems in the medical device industry. Provide guidance and support to production personnel on proper documentation practices, recordkeeping requirements, and adherence to quality system procedures.
Requirements / Skills:
Associate or bachelor’s degree in engineering or science preferred. Minimum of 2-3 years of experience in quality assurance or regulatory affairs roles within the medical device industry, with specific experience in DHR review and documentation. Strong understanding of medical device manufacturing processes, Good Manufacturing Practices (GMP), and quality system regulations (e.g., 21 CFR Part 820, ISO 13485 and/or ISO9001). Knowledge of document control principles and practices, including version control, change management, and record retention requirements. Excellent attention to detail and organizational skills, with the ability to systematically review and analyze complex documentation for accuracy and completeness. Effective communication and interpersonal skills, with the ability to collaborate with cross-functional teams and communicate findings and recommendations clearly and concisely. Proficiency in Microsoft Office applications (e.g., Word, Excel, PowerPoint) and document management systems used for electronic recordkeeping. Ability to work independently with minimal supervision, manage multiple priorities, and meet deadlines in a fast-paced and dynamic environment. JSG offers medical, dental, vision, life insurance options, short-term disability, 401(k), weekly pay, and more. Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.
#D800
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