What are the responsibilities and job description for the USA - Quality Assurance Engineer III - CTQ position at Equiliem?
Job Details
Job Title Eng, Qua, Assurance - CtQ
Summary In this contract role, is under our Commitment to Quality Program. The Quality Engineer- CtQ role is responsible for the implementation of materials master, receiving inspection plans and regulatory compliance to ensure our products meet the highest standards of quality and safety. This role works closely with cross-functional teams to create, maintain and improve our quality management systems, ensuring compliance with ISO 13485, and other regulatory requirements.
Key Responsibilities Commitment to Quality
Develop, implement, and maintain robust quality systems and procedures in line with ISO 13485, MDSAP Certifications and other industry standards.
Perform assessments to ensure adherence and commitment to quality specifications and regulatory requirements.
SAP Quality Management (QM) Integration
Create inspection plans in SAP
Use the SAP QM module to manage inspections plans, record quality data, and document quality notifications.
Ensure accurate data capture and traceability of quality-related information throughout the product lifecycle.
Set up materials-master maintenance and complete system data correction in SAP fields and inventory locations to ensure data accuracy and warehouse optimization.
Collaborate with IT, Planning, Supply Chain and production teams to optimize SAP processes for quality management.
Inspection and Testing
Provide oversight for inspections and tests of raw material, components, and assist with finished product inspections using industry standard techniques.
Review and interpret technical documents, including design specifications, engineering drawings, and regulatory standards
Risk Management & Continuous Improvement
Assist with product quality investigations, root cause analysis and CAPA facilitation to address quality issues.
Supports risk management activities, including risk assessments and mitigation plans in compliance with design controls.
Supports process improvements and facilitates PDCA process for production
Assists with Non-Conforming Material process.
Qualifications & Skills Demonstrates high level analytical skills to identify improvement opportunities and develop workable solutions to resolve complex problems
Strong attention to detail and the ability to work collaboratively in a cross-functional team.
Proactive mindset with a commitment to continuous improvement.
Education & Experience Education:
- Bachelor s degree in engineering, Quality Management or another related technical field.
Experience:
- 3 years of experience in a quality engineering role or an equivalent level of knowledge in medical devices.
- Proven hands-on experience with SAP, particularly the quality management module.
Hours: Monday to Friday 8:00AM to 5:00PM
Onsite
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.
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 .
Summary In this contract role, is under our Commitment to Quality Program. The Quality Engineer- CtQ role is responsible for the implementation of materials master, receiving inspection plans and regulatory compliance to ensure our products meet the highest standards of quality and safety. This role works closely with cross-functional teams to create, maintain and improve our quality management systems, ensuring compliance with ISO 13485, and other regulatory requirements.
Key Responsibilities Commitment to Quality
Develop, implement, and maintain robust quality systems and procedures in line with ISO 13485, MDSAP Certifications and other industry standards.
Perform assessments to ensure adherence and commitment to quality specifications and regulatory requirements.
SAP Quality Management (QM) Integration
Create inspection plans in SAP
Use the SAP QM module to manage inspections plans, record quality data, and document quality notifications.
Ensure accurate data capture and traceability of quality-related information throughout the product lifecycle.
Set up materials-master maintenance and complete system data correction in SAP fields and inventory locations to ensure data accuracy and warehouse optimization.
Collaborate with IT, Planning, Supply Chain and production teams to optimize SAP processes for quality management.
Inspection and Testing
Provide oversight for inspections and tests of raw material, components, and assist with finished product inspections using industry standard techniques.
Review and interpret technical documents, including design specifications, engineering drawings, and regulatory standards
Risk Management & Continuous Improvement
Assist with product quality investigations, root cause analysis and CAPA facilitation to address quality issues.
Supports risk management activities, including risk assessments and mitigation plans in compliance with design controls.
Supports process improvements and facilitates PDCA process for production
Assists with Non-Conforming Material process.
Qualifications & Skills Demonstrates high level analytical skills to identify improvement opportunities and develop workable solutions to resolve complex problems
Strong attention to detail and the ability to work collaboratively in a cross-functional team.
Proactive mindset with a commitment to continuous improvement.
Education & Experience Education:
- Bachelor s degree in engineering, Quality Management or another related technical field.
Experience:
- 3 years of experience in a quality engineering role or an equivalent level of knowledge in medical devices.
- Proven hands-on experience with SAP, particularly the quality management module.
Hours: Monday to Friday 8:00AM to 5:00PM
Onsite
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.
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 .
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
