Position Overview: Responsible for conducting inspections, performing tests, and ensuring compliance with quality standards throughout the manufacturing process. This role is essential in maintaining product integrity and regulatory compliance within a medical manufacturing environment.
Responsibilities:- Conduct routine inspections and testing of raw materials, in-process components, and finished medical products according to established procedures and specifications.
- Utilize various testing equipment and instruments (e.g., calipers, micrometers, tensile testers, coordinate measuring machines) to perform dimensional and functional testing.
- Record and analyze inspection and test data accurately, documenting results and deviations from quality standards.
- Identify and report non-conformities or quality issues to supervisors or quality engineers for investigation and corrective action.
- Assist in troubleshooting quality problems, participating in root cause analysis, and contributing to continuous improvement initiatives.
- Ensure compliance with regulatory requirements (e.g., FDA, ISO standards) and company quality management systems.
- Support quality audits conducted by internal and external stakeholders, providing documentation and assisting with corrective actions as needed.
- Maintain cleanliness and organization of the quality control laboratory and equipment.
- Collaborate with production teams and quality assurance colleagues to address quality concerns and implement corrective measures.
Qualifications:- High school diploma or equivalent; additional technical education or training in quality assurance, metrology, or related field preferred.
- Previous experience in quality control or inspection within a manufacturing environment, ideally in medical device manufacturing.
- Familiarity with quality control methods, testing techniques, and inspection tools used in medical manufacturing (e.g., GD&T principles, statistical process control).
- Ability to interpret technical drawings, specifications, and quality requirements.
- Proficiency in using measurement and testing equipment to verify product dimensions, tolerances, and performance.
- Strong attention to detail and ability to perform accurate and consistent quality inspections.
- Good communication skills and ability to collaborate effectively with cross-functional teams.
- Basic computer skills for data entry and report generation.
- Commitment to following safety protocols and quality assurance guidelines
Additional Notes:ARCH Medical Solutions is an Equal Opportunity Employer and wholeheartedly supports diversity in the workplace as a basic premise for business success. All employees of Arch Medical Solutions are employed on an at-will basis.This job description in no way states or implies that these are the only duties to be performed by the employee incumbent in this position. Employees will be required to follow any other job-related instruction and to perform any other job-related duties requested by any person authorized to give instructions or assignments.
A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skill, or abilities.
Equal Opportunity Employer
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