Softworld, a Kelly Company · 14 hours ago
Sr. QA Engineer
Marlborough, MA
Contract
Hybrid
Senior Level
5+ years expSoftworld, a Kelly Company, is seeking a Sr. QA Engineer to collaborate with suppliers, development teams, and manufacturing teams to perform QA activities. The role focuses on supporting Design Transfer processes and ensuring quality standards are met throughout the product lifecycle.
Human ResourcesInformation TechnologyStaffing Agency
Responsibilities
Supplier Management & SCAR Support
Support SCAR processes and manage nonconformances and rework evaluations for assigned suppliers
Handle supplier-related internal NCMRs, CAPAs, and complaint corrective actions
Manufacturing & Process Support
Provide sustaining support for process improvements and design changes transitioning into manufacturing
Assist in design transfer activities and maintain manufacturing documentation (DHRs, routers, BOMs, specifications)
Material & Product Quality
Investigate and disposition material nonconformances; participate in MRB meetings and follow up on supplier issues
Perform incoming inspection reviews and disposition of components and subsystems
Validation & Risk Management
Evaluate proposed changes to processes, equipment, or materials for validation impact
Maintain and create product-specific risk files in accordance with ISO 14971
Calibration & Documentation
Assist with calibration system maintenance
Develop and revise procedures, work instructions, and test methods
Quality Systems & Compliance
Document activities in compliance with medical standards and regulations
Lead investigations into quality issues, complaints, and audit findings
Support CAPA processes and promote QMS awareness and improvement initiatives
Supplier Audits & Approvals
Support management of new and approved suppliers
Participate in internal and supplier audits
Problem Solving & Decision Making
Use root cause analysis and problem-solving tools to implement corrective actions
Make data-driven decisions and propose solutions based on calculated risks
Qualification
Required
Working knowledge of advanced statistical methods, including Hypothesis testing, Design of Experiments (DOE), ANOVA, R&R studies, Capability analysis, Tolerance interval analysis, Power and sample size determinations
Extensive working knowledge of 21 CFR Part 820, ISO 13485
Strong proficiency in Microsoft Word and Excel
Hands-on experience with manufacturing processes such as Electro-mechanical assembly, ESD controls, Cabling, Clean room operations, Labeling, Sterilization, Fiber optics
Strong documentation skills for protocol and report generation and review
Ability to analyze quality data and trends to identify improvement opportunities
Bachelor's degree in engineering or a related technical field
5–7 years of manufacturing quality experience within the medical device industry
Experience executing process validation and test method validation / Gage R&R activities
Experience with risk management activities per ISO 14971
Preferred
Supplier management experience is preferred
Proficiency with statistical software tools (e.g., Minitab) is preferred
Prior start-up experience is a plus
Company
Softworld, a Kelly Company
Softworld has developed expertise across five distinct staffing and consulting practices over the past 25 years.
1001-5000 employees
H1B Sponsorship
Softworld, a Kelly Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (67)
2024 (90)
2023 (84)
2022 (71)
2021 (75)
2020 (80)
Funding
Current Stage
Late StageTotal Funding
unknown2021-04-06Acquired
Leadership Team
Steven Edwards
Vice President, Chief Financial Officer
Recent News
2023-01-24
Company data provided by crunchbase