Quality Systems Project Manager

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 always aware of the millions of patients we can help worldwide and are committed to meeting and exceeding our customers' high expectations. The company, headquartered in Gothenburg, Sweden, employs more than 1,500 people worldwide. In a globally growing healthcare market, we are looking for a full-time Quality Systems Project Manager to strengthen our team in Memphis, TN.

The Quality Systems Project Manager is a non-people leader role. 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/CAPA, complaints, scorecards and KPI trending, and internal / external audits. The ideal candidate embodies our values of passion, trustworthiness, result-oriented, and togetherness using them to guide effective impactful outcomes. This candidate should demonstrate professionalism, integrity, accountability, and a strong work ethic in all interactions.

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 / external stakeholders.
• Collaboration:
• Manage the analysis and investigation of products 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 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.
  

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 (21CFR820), ISO 13485, GxP and validation processes preferred
  
  

Education

• 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
  
  

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.