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Medical Coordinator Specialist
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…Portal documentation consistent with the medical clearance…
Added 1 min ago
Accounting Manager
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Farmington Hills, MI
This position will come with on-the-job training and mentorship. The onboarding process is designed to familiarize the selected candidate with our internal operations. The position will…
Added 1 min ago
T
SAT/ACT Tutor, Full Time.
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Added 2 mins ago
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- $53,000 to $57,000 USD / year
Provide staff training; evaluate staff performance and implement organizational and personnel changes as approved by the associate warden and coordinated with the human resources.
Added 2 mins ago
Professor of Practice - Public Relations
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Syracuse, NY
As determined by department chair and associate dean.
Added 2 mins ago
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Recreation Program Supervisor (Tier 1)
BOCC
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Added 3 mins ago
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Sales Associate
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- $12 to $13 USD / hour
As a Sales Associate, you are both a brand ambassador and a certified Piercing Specialist, delivering safe, professional piercing services while creating welcoming, energetic, and…
Added 3 mins ago
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Sales Associate
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Associate Account Services Coordinator
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The Associate Account Services Coordinator plays an important role in supporting the Account Services team by providing administrative, operational, and customer service support to internal…
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IT Systems Engineer
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Blender Operator I - Swing Shift
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Custodial Supervisor
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Associate - Technology Vendor Management
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Collaborate across Technology and business teams to support operational efficiency, process improvements, and vendor-related initiatives.
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Quality Assurance - QC Inspector 1st shift
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Quality Assurance - QC Inspector 1st shift
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Added 8 mins ago
Associate Director, Loyalty Giving
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This role oversees loyalty team operations, external partner relationships, and the leadership and development of staff. Working in strong collaboration with Integrated Channel Marketing to…

Trisalus Life Sciences, Inc.

Senior Quality Engineer

Westminster, CO, United States

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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%).

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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

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