SENIOR QUALITY ASSURANCE ENGINEER
3B Staffing LLC
- Medical device design controls expertise (21 CFR 820.30 / ISO 13485)
- Direct experience reviewing and auditing DHFs , not just authoring documents
- Strong working knowledge of ISO 14971 risk management , including linkage of hazards, risk controls, and residual risk
- Experience supporting or remediating DHFs in response to:
- FDA inspections
- CAPAs
- Notified Body or internal audits
- Ability to assess traceability and consistency across the DHF , not just document presence
- Hands-on experience identifying regulatory gaps vs. procedural nonconformities
- Comfortable working in partially remediated or legacy DHFs
- Senior quality/regulatory professional (not entry-level)
- Prior experience as:
- DHF auditor / reviewer
- Design controls SME
- Quality engineer supporting FDA-regulated devices
- Able to work independently, escalate findings clearly, and document gaps concisely
- Strong written communication skills for audit-facing outputs
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the SENIOR QUALITY ASSURANCE ENGINEER in Mundelein, IL vacancy
- ...Senior Quality Assurance Engineer (Design Assurance) The Senior Quality Assurance Engineer (Design Assurance) is responsible for providing oversight and governance of Design History Files (DHF) to ensure compliance with regulatory standards and internal quality requirements...Senior
- ManpowerGroup Global, Inc. is seeking an Engineer, Software Quality - Principle in Lake Forest, IL. The candidate will support the Quality Assurance department, leading projects that ensure regulatory compliance and high-quality deliverables. They must have a Bachelor’s...Senior
- Northrop Grumman Corp. (JP) is seeking a Sr. Principal Engineer, Electronics in Rolling Meadows, IL. This role involves leading efforts in modifying and sustaining testing capabilities for Electronic Warfare Systems. You will be responsible for shaping requirements, driving...Senior
- As a Sr. Project Manager, you will lead the planning, coordination, and execution of complex projects, ensuring they are delivered on time and within scope. You will serve as the central point of accountability for project performance, collaborating with internal teams...Senior
- CIEL VERNON HILLS LLC in Vernon Hills is seeking a Sales Counselor to support the marketing director and enhance community occupancy levels. The role includes managing prospective resident leads, communicating sales information, and organizing events to attract visitors...Senior
- Snap-on in Libertyville, Illinois is seeking a qualified professional for the financial accounting position focused on loan receivable subsystems. The candidate will be responsible for journal entries, reconciliations, and supporting the Finance Department with analyses...Senior
$123.4k - $185k
Northrop Grumman Corp. is seeking a Senior Principal Supplier Quality Engineer in Rolling Meadows, IL to drive the supply base towards consistently high-quality parts. The position involves engaging with suppliers, performing audits, and ensuring compliance to military...Senior$85k - $105k
...Senior Accountant We are seeking a Senior Accountant for our manufacturing client located in the northern suburbs near Libertyville. The Senior Accountant will lead key accounting functions and support accurate financial reporting, compliance, and operational...Senior- Northrop Grumman Corp. (JP) is seeking a Senior Principal Project Management Analyst in Rolling Meadows, IL. This role involves leading... ...data analysis to enhance decision-making in manufacturing engineering. The ideal candidate will have a Bachelor's degree, extensive...Senior
$43 - $47 per hour
...Software Quality Assurance Engineer Our client, a leader in healthcare diagnostics, is seeking a Software Quality Assurance Engineer to join their team. As a Software Quality Assurance Engineer, you will be part of the Quality Assurance department supporting software...Contract workTemporary workWork experience placementFlexible hours$84k - $119k
CDW is seeking a Senior Learning & Development Specialist to design and maintain a skills-based learning architecture. This role enables coworkers to adapt and thrive in a changing business environment by aligning learning pathways with critical skills and business priorities...Senior$150k - $200k
...Senior Regional Safety Manager Pay from $150,000 to $200,000 per year Corporate Headquarters 12575 Uline Drive, Pleasant Prairie, WI 53158 Safety sets the standard at Uline. From the work environment to comprehensive training and procedures, we invest...Senior- Service Construction of Illinois, Inc. in Mundelein is seeking an Estimator with a strong background in residential construction and remodeling. The ideal candidate will have at least 10 years of experience and be proficient in reading blueprints and managing multiple jobs...Senior
$100k - $120k
Antylia Scientific is seeking a Payroll Manager in Vernon Hills, IL to oversee the payroll function. This hybrid position involves managing payroll processing for multiple states and ensuring compliance with regulations. Candidates should have over 7 years of experience...Senior$85k - $105k
CFS is seeking a Senior Accountant in Mundelein, Illinois, to lead key accounting functions for a manufacturing client. The role involves overseeing close processes, financial analysis, compliance, and mentoring junior staff. The ideal candidate will have a Bachelor's...Senior$135.8k - $203.6k
Northrop Grumman Corp. (JP) is seeking a Sr. Principal Engineer, Embedded Software in Rolling Meadows, IL. This full-time position focuses on testing manufacturing engineering software in a dynamic environment and requires strong C# proficiency and experience in Agile...SeniorFull time$123.4k - $185k
Northrop Grumman Corp. (JP) is seeking a Sr. Principal Mechanical Drafting Designer in Rolling Meadows, Illinois. This role demands proficiency in CAD tools and mechanical design skills to support the design of electronic equipment for military applications. The ideal candidate...Senior- ...repairs to complex troubleshooting. The technician must ensure adherence to safety standards and company policies while promoting quality and efficiency. The ideal candidate will have at least 2 years of technical training, significant experience in maintenance, and a...Senior
- ...Senior International Trade Compliance Specialist Corporate Headquarters 12575 Uline Drive, Pleasant Prairie, WI 53158 Interested... ...regulatory hurdles, find tariff savings and bring Uline’s high quality products to international destinations. Careers Packed...Senior
- BD is seeking a Senior Manager of Marketing Research to shape the Surgery Business Unit's future. This role is pivotal in translating complex market insights into actionable strategies, ensuring BD delivers differentiated solutions in healthcare. The candidate will lead...Senior
- Ingersoll Rand is seeking a Senior Process Engineer in Vernon Hills, IL, to lead the development and optimization of molding processes for liquid silicone rubber (LSR) and high consistency rubber (HCR). You will play a critical role in driving manufacturing performance...Senior
- IFG US is seeking a Senior or Lead Analyst specializing in International Tax to join their team in Vernon Hills, Illinois. This role involves leading the preparation and review of international tax calculations and requires collaboration with regional teams to ensure compliance...Senior
- ...Senior Project Accountant Salary: 90k-110k Grow your career in construction accounting while gaining exposure to high-profile infrastructure projects. Join a team where your work directly impacts project performance and financial outcomes! Why This Opportunity...SeniorFor subcontractor
- Locinox is hiring a Senior Warehouse Specialist in Vernon Hills, IL, to enhance our U.S. operations. This role involves overseeing inventory accuracy and daily workflows, ensuring safe and efficient warehouse operations. Applicants should have at least 5 years of experience...Senior
- Stryker Corporation is seeking a Senior Research Scientist to blend I-O psychology and machine learning. This role focuses on enhancing the Jobs Engine and ensuring the scientific integrity of AI-driven insights for job analysis. The ideal candidate will have a solid background...SeniorRemote job
$100k - $120k
A leading scientific company in Vernon Hills seeks a Senior Financial Analyst to join its Finance team. This role requires strong analytical skills and financial modeling expertise to lead reporting and forecasting efforts. Responsibilities include managing operating expenses...Senior- Ingersoll Rand is seeking a Sr. Process Engineer in Mundelein, IL, responsible for optimizing molding processes for liquid silicone rubber (LSR) and high consistency rubber (HCR). The role includes troubleshooting, training, and continuous improvement efforts. Candidates...Senior
- MillenniumSoft Inc is looking for a Global Marketing Lead Manager based in Vernon Hills, IL. This senior-level role requires strong communication, Excel, and PowerPoint skills, and focuses on executing marketing activities for IV set products. The position involves planning...Senior
$80k - $100k
CFS is seeking a Senior Payroll Coordinator in Mundelein, Illinois. This position offers a hybrid work model post-training and is pivotal in managing payroll accuracy and compliance. Candidates should possess a Bachelor’s degree and over 5 years of payroll experience,...Senior- Tetra Pak is seeking a Project Manager located in Vernon Hills, Illinois. You'll manage complex engineering projects and lead a skilled team, ensuring customer satisfaction and contributing to sales results. The ideal candidate has a minimum of 5 years in project management...Senior
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to SENIOR QUALITY ASSURANCE ENGINEER. Be the first to apply!
Related searches
- senior application security Mundelein, IL
- senior vice president of operations Mundelein, IL
- senior performance tester Mundelein, IL
- senior tech Mundelein, IL
- senior manager diversity & inclusion Mundelein, IL
- senior implementation engineer Mundelein, IL
- senior software engineer remote Mundelein, IL
- senior level Mundelein, IL
- senior performance engineer Mundelein, IL
- senior customer success engineer Mundelein, IL


