job summary: Quality Engineer needed for an immediate contract role for approximately 4 months in the Burlington, MA area! The Quality Engineer will work directly with the engineering team's quality management practices. This individual will be actively involved with Corrective Action and Preventive Action (CAPA) in completing a large backlog of needs in this area. This person will also be involved in internal quality audits to ensure its adequacy, effectiveness, and adherence to established standards. The right person will have exceptional communication skills, 7+ years of related CAPA and Audit experience, knowledge of 13485 standards in working with In Vitro Diagnostic (IVD) medical devices, and the ability to gather data to complete documentation within the Quality Management System (QMS). Does this sound like you? Apply now for immediate consideration in joining a great team on the north shore! location: North Billerica, Massachusetts job type: Contract salary: $45.99 - 46.00 per hour work hours: 8am to 5pm education: Bachelors responsibilities: Ensure compliance with the organization's policies and all applicable national quality standards and regulations Provides technical support for continuous improvement efforts conducting root cause analysis then formulating and implementing corrective action proposalsWrites process procedures, change orders, equipment specifications, validation plans, and reportsIdentify and communicate risks and assist with risk mitigation plans as necessaryConducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and reportsUpdate management with periodic metrics as defined by the QA Manager. qualifications: Experience level: ExperiencedMinimum 5 years of experienceEducation: Bachelors (required) skills: QualityCorrective ActionPreventive ActionRisk ManagementMedical Device Quality Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.