Elos Medtech · 2 days ago
Senior Quality Systems Project Manager
Memphis, TN
Full-time
Hybrid
Senior Level, Lead/Staff
10+ years expElos Medtech is seeking a seasoned and strategic Quality Systems Project Manager to lead a quality system value stream in a medical device manufacturing environment. The role involves managing complex quality projects, developing processes for customer accounts, and driving results through collaboration and continuous improvement principles.
Health CareLocal BusinessManufacturingPersonal Health
Responsibilities
Lead complex quality projects, including validations, root cause investigations, and CAPA’s for multiple medical device product lines
Manage and standardize customer requirements while communicating with internal / external stakeholders
Manage the analysis and investigation of products complaints and non-conformances
Drive solution plans to completion by working with a cross functional team
Clearly communicate goals and expectations from key customers with internal team
Utilize continuous improvement principles to propose and implement changes to existing processes aimed at streamlining and improving overall performance
Maintain cost controls, creating cost effective use of resources, and ensuring quality
Lead internal and external audits, including supplier and customer audits, and prepare comprehensive audit reports and CAPA responses
Support training, internal and external audits, including FDA, ISO and Customers
Additional functions may be added at discretion of Management
Qualification
Required
Strong leadership and team-building skills
Excellent written and verbal communication
Problem-solving and decision-making ability under pressure
Proficient in interpreting production metrics and KPIs
Comfortable providing briefings at all levels of management
Excellent organizational and time management skills
Proficiency in Microsoft Office Suite (Word, Excel, Outlook, Teams, etc.)
Strong organizational and multitasking abilities
Ability to maintain discretion and handle confidential information professionally
10 plus years of experience in manufacturing or production operations, preferably within the medical device or pharmaceutical industry
Minimum of 5 years in a leadership or project management role, ideally within a value stream or lean manufacturing environment
Education: Bachelor's degree in engineering, science or equivalent technical experience
Licenses/Certificates: Industry Quality Certifications (i.e., ASQ, PMP)
Technology/Equipment: Microsoft Office Applications, Warehouse Management Applications, eQMS software
Ability to sit or stand and move within an office environment for extended periods of time
Must be able to occasionally lift and/or move up to 20 lbs
Ability to wear Personal Protective Equipment as required
Visual acuity to inspect parts, read documents, computer screens, etc
Ability to hear and verbally communicate clearly in meetings, on the phone, and in group discussions
Occasional bending, stooping, or reaching during on-site activities or workspace organization
Office-based role with regular interaction in manufacturing and cleanroom environments
Monday – Friday, standard business hours with flexibility as needed to meet project milestones
Frequent interaction with machinery, tools, and production materials
Preferred
Experience with FDA QSR (21CFR820), ISO 13485, GxP and validation processes preferred
Company
Elos Medtech
Elos Medtech employs 1,500 people in four business units – Dental, Orthopedics, Advanced Surgical and Precision - and the divisions Medical Polymer Solutions, Sterile Packaging Solutions and Medical Value Solutions.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2021-07-27Acquired
Leadership Team
Ewa Linsäter
Chief Accounting, Compliance and M&A Officer
Recent News
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2023-12-30
Squire Patton Boggs
2023-12-25
2023-11-22
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