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TS
Store Manager
The Salvation Army Central Territory
Racine, WI
- $18 to $20 USD / hour
…is crucial in supporting our mission through efficient store operations, staff management, and community engagement. You'll be responsible for overseeing all store operations, including…
Added 1 min ago
EP
Residential Counselor: University of Pennsylvania
ESF Pre-College Programs
Philadelphia, PA
- $625 USD / week
Support daily program operations, including check-in, check-out, and student transitions.
Added 1 min ago
EP
Senior Residential Counselor, On-Site Activities: University of Pennsylvania
ESF Pre-College Programs
Philadelphia, PA
- $750 USD / week
Unleash Your Potential: We offer internships, fieldwork, and professional development opportunities.
Added 1 min ago
EP
Senior Residential Counselor, Staff Culture: University of Pennsylvania
ESF Pre-College Programs
Philadelphia, PA
- $750 USD / week
…scheduling staff time off equitably and in a way that works for the program, helps schedule floor monitor and desk duty coverage liaises concerns to program leadership, and plans staff…
Added 1 min ago
EP
Senior Residential Counselor, Off-Site Activities: University of Pennsylvania
ESF Pre-College Programs
Philadelphia, PA
- $625 USD / week
…options every Saturday and Sunday depending on the size of the program group. This role collaborates with program leadership to manage the on-site administrative aspects of the trips. They…
Added 1 min ago
RH
Director, Opportunity Project
RWJBarnabas Health
Millburn, NJ
- $112,000 to $160,000 USD / year
Serves as Site Administrator and Leader for Opportunity Project, an adult Brain Injury Clubhouse program. Coordinates the daily activities of Opportunity Project which they manage along…
Added 1 min ago
Director of Student Services - East Noble School Corporation
Region 8 Education Service Center
IN
…responsible for developing consistent procedures, monitoring program effectiveness, supporting personnel development, and ensuring accountability across assigned…
Added 1 min ago
HK
School-Age Childcare Assistant Site Director – Before & After School
HEALTHY KIDS PROGRAMS
Bethel, PA
- $16 to $18 USD / hour
Healthy Kids Programs is hiring a School-Age Childcare Assistant Site Director for our Before and After School Program at Bethel Elementary School and Penn-Bernville Elementary School for…
Added 1 min ago
HK
School-Age Childcare Assistant Site Director – Before & After School
HEALTHY KIDS PROGRAMS
Bernville, PA
- $16 to $18 USD / hour
Healthy Kids Programs is hiring a School-Age Childcare Assistant Site Director for our Before and After School Program at Bethel Elementary School and Penn-Bernville Elementary School for…
Added 1 min ago
Director, Business Systems Analyst - Eagle STAR - PGIM Tech (Hybrid - Newark, NJ)
PGIM, Inc.
Newark, NJ
PGIM Quantitative Solutions is seeking an experienced Director, Business Analysis, to provide strategic leadership and oversight of business analysis capabilities supporting our investment…
Added 1 min ago
WM
Membership Coordinator
WEST MORRIS AREA YMCA
Randolph, NJ
- $22 to $25 USD / hour
…organization committed to strengthening community through youth development, healthy living and social responsibility. Under the general direction of the Membership Director, the…
Added 2 mins ago
Senior BI Engineer
BLC BACKLOTCARS Inc
Remote, United States
This role reports into the BI Manager and collaborates cross-functionally with Product, Sales, Operations, and Data Engineering teams. You will also work closely with senior leadership to…
Added 2 mins ago
Safety Manager
Webcor Construction, LP
San Francisco, CA
The Safety Manager is responsible for managing and implementing the project safety program on one project or a portion of a large, complex project. This position provides leadership,…
Added 2 mins ago
SO
Manufacturing Supervisor - 3rd shift
Scribe OpCo Inc dba Koozie Group
Red Wing, MN
- $70,000 to $85,000 USD / year
…workflow and work environment to ensure accurate and efficient operations and internal/external customer…
Added 2 mins ago
Speech Language Pathologist
Reliant Rehabilitation
Blanchester, OH
Our leadership team began their careers as therapists, and we take pride in promoting from within. You’ll be supported by a dedicated clinical team that provides ongoing training, proven…
Added 2 mins ago
Therapy Coordinator
Reliant Rehabilitation
Galion, OH
Continuing education, mentorship programs and clinical leadership development
Added 2 mins ago
Lead Registered Dietitian
Healthcare Services Group, Inc.
SAN ANTONIO, TX
Assists Director of Clinical Operations with recruiting, training, and scheduling of Registered Dietitians
Added 2 mins ago
Lead Registered Dietitian
Healthcare Services Group, Inc.
DURHAM, NC
Assists Director of Clinical Operations with recruiting, training, and scheduling of Registered Dietitians
Added 3 mins ago
HS
Dining Services Assistant Manager
Healthcare Services Group, Inc.
VINTON, VA
- From $45,000 USD / year
The Dining Services Assistant Manager is responsible for assisting the Dining Services Manager in overseeing the dining operations and ensuring high standards of food quality, safety, and…
Added 3 mins ago
HS
Food Service Worker/Kitchen Helper/Dietary Aide
Healthcare Services Group, Inc.
PORTSMOUTH, NH
- From $18 USD / hour
Maintain a positive attitude and effectively communicate with building occupants, administration, and HCSG leadership to perform daily tasks.
Added 3 mins ago
Equipment Reliability Manager
Momentum Manufacturing Group LLC
Franklin, NH
This position will lead the development, implementation and execution of the Equipment Reliability Strategy for the facility. This includes involvement and leadership in developing the TPM…
Added 3 mins ago
Department Manager
Barnes & Noble Education
WILLIAMSBURG, KY
The Department Manager is a key member of the store leadership team, responsible for leading the daily operations and overall performance of an assigned department while supporting the…
Added 3 mins ago
Project Manager I
Sundt
Maxwell, TX · Lockhart, TX
Responsible for providing leadership and management to assigned projects in a safe, profitable, and timely manner. Manages the work in a manner consistent with standards of quality and…
Added 3 mins ago
General Manager
Chipotle Mexican Grill
Hopkinsville, KY
…committed to Cultivating a Better World while sharpening your leadership and operations skills along the way. If building teams and growing a business excites you, keep reading to learn…
Added 3 mins ago
DI
Sr. Project Manager-Intralogistics
Daifuku Intralogistics America Corporation
Erlanger, KY
- $7.25 USD / hour
Follows Wynright standards for documentation and software development

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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