Equiliem
Medical Device Quality Inspector
Responsible for assuring that materials, activities, processes, and specified conditions related to the daily device manufacturing, processing and packaging meet current GMP standards and comply with applicable procedures and standards such as ensuring the quality integrity of the product. Ensure work is completed in compliance with the company quality system and medical device regulations. Ensure work is completed in compliance with the company quality system and medical device regulations.
Essential Functions • Performs one of three functions in the Quality department: o Inspecting raw materials to meet production requirements o Conducts in-process inspection of manufacturing product and processes o Reviews final documentation and shipment packaging for medical devices, subassemblies, and kits • Assists in the Madison Manufacturing documentation control room. • Completes documentation of activities performed, prepares and attaches material quality status labeling. Ensures storage and handling of product and labeling in a controlled and secure manner. • Supports Quality through occasional conduct of investigations of nonconformance, assists with preventive actions associated with the QA unit. • Performs quality reviews for quarantine releases on non-reportable, non-complaint, RMF-3 internal to an RSC.
Minimum Requirements Education / Experience / Skills: • High School diploma or equivalent • One year's experience in a regulated work environment preferred • Knowledge of FDA Quality System Regulations and ISO13485 pertaining to medical device manufacturing
Competencies: • High Level of motivation; ability to work independently • Detailed oriented • Ability to work with computer-based systems daily • Collaborator with strong levels of engagement with individuals and as a team member • Good interpersonal skills; ability to communicate well, both verbally and written
Organizational Relationship/Scope: Reports to the Quality Control Manager. This position is accountable for delivery of prompt investigative work and detailed reporting. Working across multiple functions, this position collaborates primarily with manufacturing, engineering and quality to assess nonconforming product and support supplier quality issues.
Working Conditions: Manufacturing facility of medical devices and accessories. Controlled environmental working conditions. #ZR
About Equiliem
Equiliem believes in empowering success. It's our job to cultivate relationships that connect people and employers in a way that is inclusive, intelligent, and allows both to thrive.
Across the U.S., leading companies in healthcare, government, engineering, manufacturing, professional services, and energy rely on us for their workforce solutions. Our recruiting and HR services include contract and direct hire staffing, Payrolling/EOR, Independent Contractor Compliance, and Managed Services.
For almost 30 years, we've helped shape our industry. Today, we continue to research, ask questions, and continuously enhance the candidate journey and client experience.
Benefits
We offer a comprehensive benefits package to our employees, which includes: Medical Insurance Vision & Dental Insurance Life Insurance 401K Commuter Benefits Employee Discounts & Rewards Payroll Payment Options EEO Employer
Equiliem is an equal opportunity employer. We do not discriminate or allow discrimination based on race, color, religion, creed, sex, age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Equiliem will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or (732) 238-6050 .
Responsible for assuring that materials, activities, processes, and specified conditions related to the daily device manufacturing, processing and packaging meet current GMP standards and comply with applicable procedures and standards such as ensuring the quality integrity of the product. Ensure work is completed in compliance with the company quality system and medical device regulations. Ensure work is completed in compliance with the company quality system and medical device regulations.
Essential Functions • Performs one of three functions in the Quality department: o Inspecting raw materials to meet production requirements o Conducts in-process inspection of manufacturing product and processes o Reviews final documentation and shipment packaging for medical devices, subassemblies, and kits • Assists in the Madison Manufacturing documentation control room. • Completes documentation of activities performed, prepares and attaches material quality status labeling. Ensures storage and handling of product and labeling in a controlled and secure manner. • Supports Quality through occasional conduct of investigations of nonconformance, assists with preventive actions associated with the QA unit. • Performs quality reviews for quarantine releases on non-reportable, non-complaint, RMF-3 internal to an RSC.
Minimum Requirements Education / Experience / Skills: • High School diploma or equivalent • One year's experience in a regulated work environment preferred • Knowledge of FDA Quality System Regulations and ISO13485 pertaining to medical device manufacturing
Competencies: • High Level of motivation; ability to work independently • Detailed oriented • Ability to work with computer-based systems daily • Collaborator with strong levels of engagement with individuals and as a team member • Good interpersonal skills; ability to communicate well, both verbally and written
Organizational Relationship/Scope: Reports to the Quality Control Manager. This position is accountable for delivery of prompt investigative work and detailed reporting. Working across multiple functions, this position collaborates primarily with manufacturing, engineering and quality to assess nonconforming product and support supplier quality issues.
Working Conditions: Manufacturing facility of medical devices and accessories. Controlled environmental working conditions. #ZR
About Equiliem
Equiliem believes in empowering success. It's our job to cultivate relationships that connect people and employers in a way that is inclusive, intelligent, and allows both to thrive.
Across the U.S., leading companies in healthcare, government, engineering, manufacturing, professional services, and energy rely on us for their workforce solutions. Our recruiting and HR services include contract and direct hire staffing, Payrolling/EOR, Independent Contractor Compliance, and Managed Services.
For almost 30 years, we've helped shape our industry. Today, we continue to research, ask questions, and continuously enhance the candidate journey and client experience.
Benefits
We offer a comprehensive benefits package to our employees, which includes: Medical Insurance Vision & Dental Insurance Life Insurance 401K Commuter Benefits Employee Discounts & Rewards Payroll Payment Options EEO Employer
Equiliem is an equal opportunity employer. We do not discriminate or allow discrimination based on race, color, religion, creed, sex, age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Equiliem will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or (732) 238-6050 .