Final Quality Inspector

ZipRecruiter; San Jose (CA); On-site; USD 100,000 - 125,000; Full time

Job summary

A leading company in the medical device sector seeks a Quality Inspector II to join their quality assurance team. This position involves meticulous review of Lot History Records to ensure compliance with industry standards. Candidates should have a degree in engineering or science and relevant experience in quality assurance. An eye for detail and strong organizational skills are essential for success in this role.

Qualifications

• 2-3 years in quality assurance or regulatory affairs in the medical device industry.
• Strong understanding of Good Manufacturing Practices (GMP) and quality system regulations.
• Experience with document control principles and electronic recordkeeping.

Responsibilities

• Review and verify Lot History Records for completeness and accuracy.
• Collaborate with cross-functional teams to resolve discrepancies.
• Maintain organized documentation for regulatory compliance.

Skills

Attention to Detail

Organizational Skills

Communication

Education

Associate or bachelor’s degree in engineering or science

Tools

Microsoft Office

Document Management Systems

Job description

Job DescriptionJob Description

Quality Inspector II
Full-time / Permanent
Hourly
$24.00 - $28.00

Shifts Available: Day Shift - Monday thru Friday

*We are not accepting candidates from third party agencies.

About Us:
Vantedge Medical is the premier metals-based med-tech solutions partner from concept to full-scale manufacturing. We are at the forefront of precision engineering and innovation, specializing in the development and manufacturing of vital components for medical markets such as Robotic Assisted Surgery, Orthopedics, Surgical Instruments, Dental, and more. Our teams work in unison, collaborating and problem-solving to serve the manufacturing needs of the top Medical Original Equipment Manufacturers (OEMs) around the globe. Making a difference in the lives of patients and their families drives us to go above and beyond every day. With a steadfast commitment to advancing medical technology, we take immense pride in the work we do – and have a lot of fun doing it.

About this Opportunity:

Vantedge Medical is seeking a meticulous and detail-oriented Device History Record (DHR) Reviewer to join our quality assurance team. 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 .
• 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.