Elos Medtech AB
Overview
Elos Medtech, a leading development and production partner for medical technology companies worldwide. At our locations in Sweden, Denmark, Switzerland, Germany, China, and the USA, Elos runs operations in four business areas - Dental, Orthopedics, Advanced Surgical and Precision. Elos Medtech has extensive expertise and specializes in development and design, along with contract manufacturing of medical devices, such as implants and instruments. We are headquartered in Gothenburg, Sweden, and employ more than 1,500 people worldwide. We are looking for a full-time Quality Systems Project Manager to strengthen our team in Memphis, TN. The Quality Systems Project Manager will lead a quality system value stream to achieve excellence in safety, quality, delivery, and cost in a medical device manufacturing environment. This role is responsible for developing processes to ensure suitability of key customer accounts, non-conformance investigation and CAPA, complaints, scorecards and KPI trending, and internal / external audits. The ideal candidate embodies our values of passion, trustworthiness, result-orientation, and togetherness and uses them to guide effective, impactful outcomes. This candidate should demonstrate professionalism, integrity, accountability, and a strong work ethic in all interactions. Responsibilities
Lead complex quality projects, including validations, root cause investigations, and CAPAs for multiple medical device product lines. Manage and standardize customer requirements while communicating with internal and external stakeholders. Manage the analysis and investigation of product 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 the internal team. Utilize continuous improvement principles to propose and implement changes to existing processes aimed at streamlining and improving overall performance. Maintain cost controls, create cost-effective use of resources, and ensure quality. Lead internal and external audits, including supplier and customer audits, and prepare comprehensive audit reports and CAPA responses. Support training and audits, including FDA, ISO and Customer requirements. Additional functions may be added at the discretion of Management. Requirements
Skills
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 Experience
3-5 years of experience in manufacturing or production operations, preferably within the medical device or pharmaceutical industry Minimum of 3 years in a leadership or project management role, ideally within a value stream or lean manufacturing environment Experience with FDA QSR (21 CFR 820), ISO 13485, GxP and validation processes preferred Education
Bachelor’s degree in engineering, science or equivalent technical experience Industry Quality Certifications (e.g., ASQ, PMP) Microsoft Office Applications, Warehouse Management Applications, eQMS software Physical Demands
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 Working Conditions
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 Reporting Structure : This position will report to the Quality Manager.
#J-18808-Ljbffr
Elos Medtech, a leading development and production partner for medical technology companies worldwide. At our locations in Sweden, Denmark, Switzerland, Germany, China, and the USA, Elos runs operations in four business areas - Dental, Orthopedics, Advanced Surgical and Precision. Elos Medtech has extensive expertise and specializes in development and design, along with contract manufacturing of medical devices, such as implants and instruments. We are headquartered in Gothenburg, Sweden, and employ more than 1,500 people worldwide. We are looking for a full-time Quality Systems Project Manager to strengthen our team in Memphis, TN. The Quality Systems Project Manager will lead a quality system value stream to achieve excellence in safety, quality, delivery, and cost in a medical device manufacturing environment. This role is responsible for developing processes to ensure suitability of key customer accounts, non-conformance investigation and CAPA, complaints, scorecards and KPI trending, and internal / external audits. The ideal candidate embodies our values of passion, trustworthiness, result-orientation, and togetherness and uses them to guide effective, impactful outcomes. This candidate should demonstrate professionalism, integrity, accountability, and a strong work ethic in all interactions. Responsibilities
Lead complex quality projects, including validations, root cause investigations, and CAPAs for multiple medical device product lines. Manage and standardize customer requirements while communicating with internal and external stakeholders. Manage the analysis and investigation of product 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 the internal team. Utilize continuous improvement principles to propose and implement changes to existing processes aimed at streamlining and improving overall performance. Maintain cost controls, create cost-effective use of resources, and ensure quality. Lead internal and external audits, including supplier and customer audits, and prepare comprehensive audit reports and CAPA responses. Support training and audits, including FDA, ISO and Customer requirements. Additional functions may be added at the discretion of Management. Requirements
Skills
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 Experience
3-5 years of experience in manufacturing or production operations, preferably within the medical device or pharmaceutical industry Minimum of 3 years in a leadership or project management role, ideally within a value stream or lean manufacturing environment Experience with FDA QSR (21 CFR 820), ISO 13485, GxP and validation processes preferred Education
Bachelor’s degree in engineering, science or equivalent technical experience Industry Quality Certifications (e.g., ASQ, PMP) Microsoft Office Applications, Warehouse Management Applications, eQMS software Physical Demands
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 Working Conditions
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 Reporting Structure : This position will report to the Quality Manager.
#J-18808-Ljbffr