Elos Medtech
Elos Medtech is a leading development and production partner for medical technology companies worldwide, operating in Sweden, Denmark, Switzerland, Germany, China, and the USA across four business areas—Dental, Orthopedics, Advanced Surgical, and Precision. The company specializes in the development, design, and contract manufacturing of medical devices, including implants and instruments.
Role Summary 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, investigating non-conformance and CAPA, handling complaints, managing scorecards and KPI trending, and conducting internal and external audits.
Essential Job Functions
Project Management
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 and external stakeholders.
Collaboration
Manage the analysis and investigation of product complaints and non-conformances.
Drive solution plans to completion by working with a cross‑functional team.
Set Direction and Drive Results
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.
Lead internal and external audits, including supplier and customer audits, and prepare comprehensive audit reports and CAPA responses.
Support training and internal and external 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 in manufacturing or production operations, preferably within the medical device or pharmaceutical industry.
Minimum 3 years in a leadership or project‑management role, ideally within a value‑stream or lean manufacturing environment.
Experience with FDA QSR (21CFR820), ISO 13485, GxP and validation processes preferred.
Education
Bachelor’s degree in engineering, science or equivalent technical experience.
Industry Quality Certifications (ASQ, PMP) preferred.
Microsoft Office Applications, Warehouse Management Applications, eQMS software.
Physical Demands
Ability to sit or stand and move within an office environment for extended periods.
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.
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Role Summary 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, investigating non-conformance and CAPA, handling complaints, managing scorecards and KPI trending, and conducting internal and external audits.
Essential Job Functions
Project Management
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 and external stakeholders.
Collaboration
Manage the analysis and investigation of product complaints and non-conformances.
Drive solution plans to completion by working with a cross‑functional team.
Set Direction and Drive Results
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.
Lead internal and external audits, including supplier and customer audits, and prepare comprehensive audit reports and CAPA responses.
Support training and internal and external 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 in manufacturing or production operations, preferably within the medical device or pharmaceutical industry.
Minimum 3 years in a leadership or project‑management role, ideally within a value‑stream or lean manufacturing environment.
Experience with FDA QSR (21CFR820), ISO 13485, GxP and validation processes preferred.
Education
Bachelor’s degree in engineering, science or equivalent technical experience.
Industry Quality Certifications (ASQ, PMP) preferred.
Microsoft Office Applications, Warehouse Management Applications, eQMS software.
Physical Demands
Ability to sit or stand and move within an office environment for extended periods.
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.
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