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Elos Medtech · 1 day ago

Senior Quality Systems Project Manager

Memphis, TN

Full-time

Onsite

Senior Level, Lead/Staff

10+ years exp

Elos Medtech is a leading development and production partner for medical technology companies worldwide. They are seeking a Senior Quality Systems Project Manager to lead quality system initiatives in a medical device manufacturing environment, focusing on improving safety, quality, and delivery while managing customer requirements and internal audits.

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

Qualification

FDA QSR knowledgeISO 13485 knowledgeLeadership skillsProject managementMicrosoft Office proficiencyProblem-solving abilityCommunication skillsMultitasking abilitiesTeam-building skillsOrganizational skillsTime managementConfidentiality

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 3 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

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

Industry Quality Certifications (i.e., ASQ, PMP)

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.

Founded in 1923

Gothenburg, Vastra Gotaland, SWE

1001-5000 employees