Equiliem
Medical Device Quality Inspector
Responsible for assuring that materials, activities, processes, and specified conditions related to daily device manufacturing, processing and packaging meet current GMP standards and comply with applicable procedures and standards, ensuring product quality integrity.
Essential Functions
Perform one of three functions in the Quality department:
Inspect raw materials to meet production requirements
Conduct in-process inspection of manufacturing product and processes
Review final documentation and shipment packaging for medical devices, subassemblies, and kits
Assist in the Madison Manufacturing documentation control room.
Complete documentation of activities performed, prepare and attach material quality status labeling, ensuring storage and handling are controlled and secure.
Support Quality through investigations of nonconformance, assist with preventive actions associated with the QA unit.
Perform quality reviews for quarantine releases on non-reportable, non-complaint, RMF-3 internal to an RSC.
Minimum Requirements
High School diploma or equivalent.
One year’s experience in a regulated work environment preferred.
Knowledge of FDA Quality System Regulations and ISO 13485 pertaining to medical device manufacturing.
Competencies
High motivation; ability to work independently.
Detail-oriented.
Proficiency with computer-based systems.
Strong collaboration and engagement with individuals and teams.
Good interpersonal skills; effective verbal and written communication.
Organizational Relationship/Scope Reports to the Quality Control Manager. This position is accountable for prompt investigative work and detailed reporting, collaborating 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.
About Equiliem Equiliem believes in empowering success, cultivating inclusive relationships that allow people to thrive. For almost 30 years, we have helped shape the industry, researching, questioning, and enhancing the candidate journey and client experience.
Benefits
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.
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Essential Functions
Perform one of three functions in the Quality department:
Inspect raw materials to meet production requirements
Conduct in-process inspection of manufacturing product and processes
Review final documentation and shipment packaging for medical devices, subassemblies, and kits
Assist in the Madison Manufacturing documentation control room.
Complete documentation of activities performed, prepare and attach material quality status labeling, ensuring storage and handling are controlled and secure.
Support Quality through investigations of nonconformance, assist with preventive actions associated with the QA unit.
Perform quality reviews for quarantine releases on non-reportable, non-complaint, RMF-3 internal to an RSC.
Minimum Requirements
High School diploma or equivalent.
One year’s experience in a regulated work environment preferred.
Knowledge of FDA Quality System Regulations and ISO 13485 pertaining to medical device manufacturing.
Competencies
High motivation; ability to work independently.
Detail-oriented.
Proficiency with computer-based systems.
Strong collaboration and engagement with individuals and teams.
Good interpersonal skills; effective verbal and written communication.
Organizational Relationship/Scope Reports to the Quality Control Manager. This position is accountable for prompt investigative work and detailed reporting, collaborating 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.
About Equiliem Equiliem believes in empowering success, cultivating inclusive relationships that allow people to thrive. For almost 30 years, we have helped shape the industry, researching, questioning, and enhancing the candidate journey and client experience.
Benefits
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.
#J-18808-Ljbffr