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job summary: Sr Quality Engineer needed for direct-hire position in the Burlington, Massachusetts area. This person will work closely with all levels of the engineering, finance, production, purchasing, facilities, and EHS departments to ensure systems and processes throughout the facility align with quality standards. This Quality Engineer will have proven experience within a manufacturing environment. In this role you will be expected to exercise sound technical judgment when analyzing data gathered from internal monitoring, while implementing and sustaining suitable processes, while driving continuous improvement. The right person for this role must have proven attention to detail, effective Communication/ follow up, and the ability to prioritize and work independently. This person will have 5+ years of experience maintaining quality management systems, ideally within AS9100D and ISO9001:2015 manufacturing environment. Candidates with experience in IATF16949 or ISO13485 will also be considered. Apply now for immediate consideration!   location: Burlington, Massachusetts job type: Permanent salary: $115,000 - 130,000 per year work hours: 8am to 4pm education: Bachelors   responsibilities: Develops and implements quality documentation such procedures, work instructions, single-point lessons, etc.Collaborates with Quality Manager and Operations Manager to develop and implement controls and improvementsWork with Engineering and Quality to determine the appropriate measuring methods and tools to carry out inspectionsPerforms RCCA utilizing PDCA/DMAIC, or other problem-solving methodology to resolve issuesDetermine and implement robust corrective and preventive actionsLead formal problem-solving teams to resolve important quality issuesInterface with customers and suppliers, as required, to resolve quality issuesWork with cross-functional teams to facilitate the execution of PFMEAs, Control Plans, and Process FlowchartsSupport the Materials Review Board (MRB) in investigating and dispositioning of NCRs. When warranted, submit NCRs/CAPAs/Information to customers for dispositionWorks with ProLink SPC software Required Skills and Experience 5+ years of demonstrated experience in maintaining AS9100D and ISO9001:2015 Quality Management Systems in a manufacturing environment. Will consider experience in IATF16949, or ISO13485.Experience with Heat Treat and Welding desired, and experience with Nadcap is a plusExperience working with cross-functional teams, ideally across multiple sites and time zonesSound analytical skills. Able to see the big picture, remain focused and composed while shuffling multiple demands to make appropriate decisions.Microsoft Office (Word, Excel, PowerPoint, Access, Outlook) experience along with the ability to write reports in clear, grammatically correct, English.   qualifications: Experience level: ExperiencedMinimum 1 year of experienceEducation: Bachelors  skills: QualityAS9100D and ISO9001 2015 QMSHeat TreatGD&TAPQP, PPAPProcess Flow ChartsDFMEAPFMEAControl Plans Problem-solving Manufacturing 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 health, an incentive and recognition program, and 401K contribution (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.

job summary: A Process Engineer is needed for a global healthcare leader that discovers, develops and distributes therapeutic solutions focused on patient's needs in the Framingham, MA area. The Process Engineer role will focus on developing and implementing advanced process modeling and digital technologies, such as digital twins and PAT, to optimize and control biopharmaceutical manufacturing processes, requiring expertise in mechanistic modeling, Python programming, and cross-functional collaboration.   location: Framingham, Massachusetts job type: Contract salary: $58.89 - 82.45 per hour work hours: 8am to 5pm education: Masters   responsibilities: Develop mechanistic and hybrid models to predict and understand Drug Substance (DS) and Drug Product (DP) processes.Implement digital twins, Process Analytical Technology (PAT) like Raman spectroscopy for real-time monitoring and control.Enable Right-First-Time (RFT) process tech transfer and scale-up.Use modeling expertise to support process investigations and continuous improvement initiatives.Work closely with R&D, Manufacturing, Quality, and Digital teams, as well as external partners. Skills: Proficiency in mechanistic/hybrid modeling and chemometric modeling (e.g., PAT Raman).Advanced data analysis and programming skills, particularly in Python.strong understanding of cell culture and bioreactor operations is a plus. Education and Experience: Master's or Ph.D. in Chemical/Biochemical Engineering or a related field.3+ years of relevant experience in biopharmaceutical process modeling and control. #LI-RB1   qualifications: Experience level: ExperiencedEducation: Masters  skills: Professional EngineermodelingAutomationPython 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 health, an incentive and recognition program, and 401K contribution (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.

job summary: A Supplier Engineer is needed for a manufacturing company considered one of the world's leading innovators in materials science. Remote work. This role is responsible for ensuring supplier compliance with medical device regulations by managing quality agreements, reviewing product labels, coordinating with suppliers and internal teams, and driving supplier management and compliance initiatives.   location: Remote, Remote job type: Contract salary: $27.71 - 38.79 per hour work hours: 8am to 5pm education: Associates   responsibilities: Ensure compliance of suppliers providing raw materials, components, outsourced services, and purchased finished goods (PFGs) for medical devices.Collaborate with internal teams (Manufacturing, Quality, Engineering, Procurement, Supplier Quality) to identify and manage supplier compliance requirements.Work with Supplier Quality to establish and maintain Quality Agreements with identified suppliers.Review labels of finished goods (FGs) and purchased finished goods (PFGs) to ensure compliance with relevant industry standards.Coordinate with suppliers and Contract Manufacturing Organizations (CMOs) to validate Medical Device Files in accordance with applicable regulations.Conduct supplier audits and assessments as needed to ensure adherence to industry standards (e.g., ISO 13485, ISO 9001).Lead projects related to supplier management, compliance, and quality improvement initiatives. Skills: strong understanding of medical device regulations and quality requirements.Proficiency in Microsoft Office (Excel, Word, PowerPoint).Ability to work independently with excellent time management and prioritization skills.strong communication (written and verbal) and interpersonal skills.Ability to influence and collaborate with cross-functional teams without direct authority.Problem-solving and analytical thinking skills.Experience in change management and process improvement.strong organizational skills and attention to detail.Ability to manage multiple projects and effectively handle conflicts. Edcuation and Experience: Associate's degree + 3 years of relevant experience orHigh School Diploma + 10 years of equivalent experience.Minimum of 3 years of experience in a regulated industry.Knowledge of industry standards such as ISO 9001, ISO 13485. #LI-KD1   qualifications: Experience level: ExperiencedEducation: Associates  skills: Supplier QualityComplianceMedical Device 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 health, an incentive and recognition program, and 401K contribution (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.