Jobs in the United States

25+ jobs

Save this search

Added just now
HC
Library Specialist I (LaPorte Branch Library)
Harris County
La Porte, TX
- $20 USD / hour
Added 1 min ago
AU
Assistant Men's & Women's Golf Coach (part time)
Arcadia University
Glenside, PA
- Part-time
Experience with Front Rush or similar recruiting software preferred.
Added 1 min ago
TO
Pharmacist/Informaticist
Tohono O'odham Nation Healthcare
Sells, AZ
- From $175,090.45 USD / year
The incumbent is a specialist/integratory in the local implementation and ongoing support of multi-service clinical software applications.
Added 1 min ago
Jr. ML Developer
Herndon, VA
As a Junior Machine Learning Developer, you will play a critical role in supporting the design, development, and deployment of machine learning models that drive data-driven decision-making…
Added 1 min ago
Senior Staff Engineer, Layout Design
Samsung Semiconductor
San Jose, CA
To provide the best candidate experience amidst our high application volumes, each candidate is limited to 10 applications across all open jobs within a 6-month period.
Added 1 min ago
IT Administrator
Integrated Production Systems, Inc
ARLINGTON, TX
…mobile devices, Microsoft 365 (GCC High) and line-of-business applications within defined response…
Added 2 mins ago
FINANCIAL ANALYST - 71002371
State of Florida
TALLAHASSEE, FL
Reviewing all grant applications and amendments; ensures they meet the requirements set forth in FDLE Grant Policy 1.10; and facilitates the department’s grant routing process;
Added 2 mins ago
Financial Advisor Trainee-Mount Pleasant, SC
Raymond James & Associates, Inc.
Mount Pleasant, SC
Operating client relationship manager system and other required software applications to produce financial plans, correspondence, reports, electronic communication, spreadsheets, and…
Added 2 mins ago
Client Service Associate (Scottsdale, AZ)
Raymond James & Associates, Inc.
Scottsdale, AZ
Operate standard office equipment and using required software applications to produce correspondence, reports, electronic communication, spreadsheets, and databases.
Added 2 mins ago
AI Delivery Engineer - AWS Bedrock
Kunai
Remote, United States
…work alongside client teams to turn business problems into AI applications that people use every day. You join a multidisciplinary delivery pod and take work from first discovery workshop…
Added 2 mins ago
I
Stop Loss Claims Specialist
Imagine360
United States
- $40,000 to $60,000 USD / year
Working knowledge of computers and software including but not limited to Microsoft Office products
Added 2 mins ago
I
Medical Claims Administrator
Imagine360
United States
- $45,000 to $55,000 USD / year
Working knowledge of computers and software including but not limited to Microsoft Office products
Added 2 mins ago
S
SciTec Internship - Princeton 2027
SciTec
Princeton, NJ
- $24 to $26 USD / hour
Are you a talented software/computer engineer? Do you work well in an agile, collaborative team environment? Do you have a passion for developing software? Are you skilled in business…
Added 3 mins ago
Lead Clinical Documentation Improvement - Hybrid
CHS
Franklin, TN · Laredo, TX
Proficiency with CDI software, encoder tools, electronic medical records, and standard office software applications.
Added 3 mins ago
Lead Clinical Documentation Improvement - Hybrid
CHS
Franklin, TN · Tucson, AZ
Proficiency with CDI software, encoder tools, electronic medical records, and standard office software applications.
Added 3 mins ago
Java Full Stack Software Engineer - Mid Level
United Services Automobile Asn
United States
As a dedicated Java Full Stack Software Engineer - Mid Level, you will join a dynamic, startup-minded team within the Investment Experience Technology organization at USAA, part of the…
Added 3 mins ago
Development Product Owner Senior | Auto National Product
United Services Automobile Asn
United States
Advanced knowledge of multiple technical software delivery methodologies (i.e., Agile, Waterfall, SAFe).
Added 3 mins ago
SA
Tech Lead Software Engineer
Southwest Airlines
Dallas, TX
- $160,550 to $178,400 USD / year
Ready to lead the technology that powers critical HR and payroll experiences across Southwest? As a Tech Lead Software Engineer, you will lead a Team of developers while serving as the…
Added 3 mins ago
P
Assistant Property Manager
Pennrose
Atlanta, GA
- $23 to $25 USD / hour
Reviews and screens all applications for Property Manager’s approval
Added 3 mins ago
Design Engineer
Ralliant
Chandler, AZ
Experience using 3D CAD software (SolidWorks preferred; equivalent CAD platforms acceptable).
Added 3 mins ago
Structural Engineer 1 (Entry-Level) - Nuclear (January 2027)
Sargent & Lundy
Atlanta, GA
Familiarity with structural analysis software such as MathCad, STAAD PRO, SAP2000, SAFE, GT STRUDL, or ANSYS
Added 3 mins ago
Sr. Software Engineer
Brady Corporation
Boston, MA
Brady Corporation is seeking a Senior Software Engineer to join our Applications Engineering team, building high-quality software for our external and internal customers. You’ll design,…
Added 4 mins ago
MH
Registered Nurse Assistant Director of Nursing for Psychiatric Services
MedStar Health
Baltimore, MD
- $49.33 to $86.1 USD / hour
Added 4 mins ago
Community Manager - Madison at Melrose
Greystar Management Services, LLC
Richardson, TX
Oversees the lease enforcement process by approving prospective resident applications, discounts and renewal leases, conducts periodic apartment inspections, follows proper notice…
Added 4 mins ago
Community Manager - Indigo Cove
Greystar Management Services, LLC
Bluffton, SC
Oversees the lease enforcement process by approving prospective resident applications, discounts and renewal leases, conducts periodic apartment inspections, follows proper notice…

Trisalus Life Sciences, Inc.

Senior Quality Engineer

Westminster, CO, United States

Apply About employer

Applications open in a new tab.

Job details

Experience: 8+ years of Quality Engineering experience in the medical device, pharma, or combination product industry.
Posting language: English

Original job description

• Serve as a technical authority and subject matter expert for quality engineering activities across the product lifecycle at TriSalus Life Sciences. The Sr. Quality Engineer provides senior-level technical leadership, mentors junior quality engineers, drives enterprise-wide quality system improvement initiatives, and leads complex cross-functional projects to ensure full alignment with FDA regulations, ISO 13485 requirements, and all applicable standards. This role is distinguished from entry level Quality Engineers by its broader organizational influence, independent project ownership, and role as an internal expert and escalation resource.

Supplier Controls: Own and lead the supplier quality management program enterprise-wide. Define supplier performance standards, manage the supplier performance monitoring workstream, and drive corrective action activities to prevent recurrence. Develop and execute the supplier management audit schedule; serve as the primary escalation point for critical supplier non-conformances. Provide strategic recommendations for supplier qualification and disqualification decisions.
Manufacturing Quality Engineering: Serve as the technical authority for manufacturing quality. Lead the development of inspection plans, drive advanced root cause analysis for complex defects, and own continuous improvement initiatives with Sustaining Engineering. Independently assess and resolve systemic quality issues impacting production performance.
Process Validation / Monitoring: Lead and own process validation and monitoring programs, including IQ/OQ/PQ, Test Method Validation, and Gage R&R. Develop Quality Plans and implement statistically-based product and process quality monitoring. Serve as the internal expert and escalation resource for validation activities across the organization.
Sterility Assurance: Serve as the organizational subject matter expert for TriSalus sterility assurance compliance. Own the technical relationship with contract sterilization and testing services. Lead process change control, deviation management, BI testing oversight, and periodic requalification/revalidation. Advise R&D and Operations on sterilization strategy and regulatory guidance for new and existing products.
External Standards: Manage the External Standards workstream. Ensure that the External Regulatory Documents applicable to the TriSalus medical device business (EXT-0001) document is maintained and current based on notifications from regulations and standards publication suppliers. Submit new/revised standards into Veeva Vault in a timely fashion. Help assign and/or perform gap assessments and implement changes for revised standards that impact TriSalus devices..
Calibration: Lead the development and continuous improvement of in-house calibration capabilities. Define equipment requirements, draft and approve procedures, and oversee training and execution of calibration activities in collaboration with R&D and Operations.

• • •

Internal Audit: Participate in the internal audit program, including serving as lead auditor and audit program owner. Ensure timeliness objectives are met and quality records are properly maintained. Mentor junior engineers in audit methodology.
Non-Conforming Materials: Drive timely investigation, disposition, and execution activities. Provide performance metrics and trend analysis to leadership; ensure all NCR quality records are properly maintained.
Corrective and Preventive Actions:. Identify systemic quality issues and trends, lead root cause analysis, and manage corrective and preventive actions to ensure Quality Objectives are met. Provide performance metrics and ensure proper documentation.
Root Cause Analysis / Statistical Techniques: Serve as the organizational expert in root cause analysis and statistical tool applications. Provide training and coaching across the quality and operations organizations.
Computer Software Assurance: Lead or provide senior technical oversight to CSA activities. Collaborate with Operations and R&D on software validation and monitoring, including software assessment and revision control.

General:

Serve as a key participant and technical leader during regulatory site audits (front/back room).
Generate, review, and approve Quality Plans; provide final sign-off on complex validation and quality documents.
Generate change orders to ensure procedures comply with current processes and regulations; approve changes initiated by others.
Prepare and present metrics, trend analysis, and strategic recommendations during Management Review meetings.
Mentor and develop Sr. Quality Engineers and Associate Quality Engineers; support their professional growth and technical capability.
Perform final traveler review and finished device release to finished goods as needed.
Education & Certifications:
BS in Engineering, Science, Biomedical, or related field required.
CQA or Lead Assessor certification required.
CQE certification preferred.
ASQ Certified Quality Engineer (CQE) or equivalent strongly preferred
Valid passport required.
Work Experience:
8+ years of Quality Engineering experience in the medical device, pharma, or combination product industry.
Demonstrated experience leading quality programs, owning complex workstreams, and serving as a technical authority.
Experience in the manufacture of medical devices or pharmaceuticals required.
Experience mentoring or developing junior quality engineering staff.
Experience with intravascular devices a plus.
Experience with drug product manufacturing a plus
Knowledge, Skills & Abilities:
Deep knowledge and application of US and international standards: FDA 21 CFR 820, ISO 13485, ISO 14971, ISO 10993, ISO 11135, ISO 11607, ISO 11737, and ISO 14644.
Expert-level application of root cause analysis, statistical techniques, SPC, DOE, and problem-solving methodologies.
Ability to independently lead complex, cross-functional quality projects with minimal supervision.
Strong technical writing skills; ability to author, review, and approve quality system documents.
Adept in Microsoft Excel, Minitab, Word, PowerPoint, SharePoint, Outlook, and Teams.
Demonstrated ability to influence across functions and drive quality culture at an organizational level.
Excellent communication skills (oral and written); able to present to senior leadership and regulatory authorities.
Strong sense of urgency, attention to detail, and ability to manage multiple high-priority workstreams simultaneously.
Physical Requirements:
Ability to safely and successfully perform essential job functions consistent with ADA, FMLA, and applicable federal, state, and local standards.
Ability to maintain regular, punctual attendance consistent with ADA, FMLA, and applicable standards.
Must be able to lift and carry up to 30 lbs.
Must be able to talk, listen, and speak clearly on telephone and video conference.
Must be able to travel overnight and internationally (<15%).

Apply About employer

More about this job

Skills

Leadership
Quality assurance procedures
Vendor management
Inspection
Root cause analysis
Process improvement
SAP IQ
Regulatory compliance
Auditing
Documentation
Provide training
Coaching
Medical devices
SPC
Problem solving
Technical writing
Microsoft Excel
Minitab
Microsoft Word
Microsoft PowerPoint
Microsoft SharePoint
Microsoft Outlook
Microsoft Teams
Communication skills
Attention to detail

Report this job