Sr. Quality Systems Project Manager

Elos Medtech; Memphis (TN); On-site; USD 110,000 - 170,000; Full time

Job summary

Elos Medtech is seeking a seasoned Quality Systems Project Manager to lead a value stream focused on safety, quality, delivery, and cost in a medical device manufacturing environment.

The role drives CAPA investigations, audits (FDA/ISO), and KPI trending, working with internal and external stakeholders to ensure regulatory compliance and continuous improvement.

Qualifications

• Bachelor’s degree in engineering, science or equivalent technical experience.
• Industry Quality Certifications (i.e., ASQ, PMP) preferred or required.

Responsibilities

• Lead complex quality projects, including validations, root cause investigations, and CAPA’s for multiple medical device product lines.
• Manage and standardize customer requirements with internal/external stakeholders.
• Analyze and investigate product complaints and non-conformances.
• Drive solution plans with a cross-functional team.
• Lead internal and external audits, including supplier and customer audits, and prepare audit reports and CAPA responses.

Skills

Strong leadership

Problem solving

KPIs interpretation

Briefing at management levels

Organizational skills

MS Office proficiency

Multitasking

Confidential info handling

Education

Bachelor's degree in engineering/science

Quality certifications (ASQ, PMP)

Tools

Microsoft Office Applications

Warehouse Management Applications

eQMS software

Job description

We are seeking a seasoned and strategic Quality Systems Project Manager. This is a non-people leader role. The Quality Systems Project Manager role 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.
• 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
• 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:

• 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
• 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 be reports to the Director of Engineering & Quality