job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. As the world's leading provider of diagnostic information services, our client is committed to sharing our purpose, strategy, and culture-through working every day to uncover important insights about your health. We're dedicated to providing actionable results that empower you with the information you need to make your healthcare decisions count - apply for your dream job now! location: Marlborough, Massachusetts job type: Contract salary: $69.00 - 69.70 per hour work hours: 9 to 5 education: Bachelors responsibilities: Job Description This role ensures that the client's' IVD products meet stringent regulatory requirements and quality standards. The Staff Quality Engineer will lead quality engineering initiatives, support product development and manufacturing processes, and drive continuous improvement in the quality management system. Duties and Responsibilities: Develop, implement and maintain quality systems and processes in compliance with FDA CFR Part 820, ISO 13485, IVDR 2017/746, ISO 14971 and other regulations, as appropriate, for IVD products Conduct hazard analysis and risk assessments for IVD products according to ISO14971 throughout the IVD product lifecycle Lead internal and external audits, including preparation, execution, and follow-up to ensure adherence to quality and client standards and regulatory requirements Oversee corrective and preventive action (CAPA) processes, non-conformance investigations and deviations to resolve quality issues Collaborate with cross-functional product development teams to integrate quality requirements into product design, verification and validation activities according to Design Controls Review and approve design control documentation including design inputs, design outputs, verification/validation protocols and reports, and risk management documentation. Assess and qualify new suppliers in product development and throughout the product lifecycle. Establish and maintain Design History File for IVD products Establish, monitor and analyze quality metrics, trends and performance data to identify areas of improvement Support regulatory submissions and activities for IVD product approvals Support complaints process (review, process, investigate, trend quality data, etc.) and post-market incident activities. Support post-market incident activities Manage post-market incident activities (field action, MDRs, EU incident decision/reporting, field failure trending). Maintain knowledge of laboratory regulatory requirements, including accrediting bodies, federal, state, and local requirements as well as Quest Diagnostics policies. Drive continuous improvement initiatives in design control and risk management processes, leveraging industry best practices, lessons learned, and feedback from audits and post-market surveillance data Stay current with evolving regulatory requirements, standards, and industry trends Proactively update internal processes, policies and procedures, and training materials as needed Drive continuous improvement initiatives in design control and risk management processes, leveraging industry best practices, lessons learned, and feedback from audits and post-market surveillance data Stay current with evolving regulatory requirements, standards, and industry trends Proactively update internal processes, policies and procedures, and training materials as needed Follow corporate policies and procedures Perform other duties as assigned. qualifications: Required Work Experience: 8+ years of experience in Medical Devices and/In Vitro Diagnostics (IVD) design and development with a strong focus on design control and risk management Preferred Work Experience: Experience in working effectively in an FDA-regulated environmentExperience working with IVD productsAnalytical mindset with attention to detail and a commitment to integrity, product safety, and QualityDemonstrated Experience applying medical device regulations (e.g.IEC 62304, FDA 21 CFR Part 803, 21 CFR Part 806, 21 CFR Part 820, ISO 13485, ISO 14971, IVDR, CAP, and CLIA). Knowledge: Experience with quality management system development, Design Controls, and risk management Skills: Communication (verbal and written), ability to build and manage an effective team, being able to influence others and drive for results, effective presentation skills, problem solving Competencies: Demonstrate ability to influence and create changeStrong interpersonal communication skillsDemonstrate strong writing and composition skillsDemonstrate success in motivating team members to reach objectives Business Process Skills Able to effect Quality Improvement through problem solving skills and knowledge of quality toolsAble to lead and drive changeOrganization skillsProject and team management skillsAnalytical and problem-solving skillsProficient in Microsoft Word, Excel, and PowerpointAble to function in a matrix organizationFlexibility to meet continuously changing priorities and challengesRequires ability to understand, interpret and apply quality and regulatory requirements. Work Environment: Prolonged sitting at a desk (i.e., operating a computer, telephone use, document review)Walking or standing within the office area to operate other office equipment (i.e. printer / fax) or within the laboratoryRequired to wear PPE as appropriate when visiting testing locationsMust frequently respond to text/email communications and will be required to be aware of ergonomic principlesMay be required to travel by airplane /train or drive long distancesAbility to follow verbal or written instructions and use effective verbal and written communication Education Bachelor's Degree (Required) skills: Process Engineering, Quality Control Testing, Quality Management Systems (QMS) 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.