Senior Quality Engineer for Medical Devices & Audits

Mativ Holdings, Inc.

Alpharetta, Northern (GA, KY)

Hybrid

USD 110,000 - 150,000

Full time

12 days ago
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Job summary

Mativ Holdings, Inc. is seeking a Senior Quality Engineer to act as the primary quality interface for customers in Medical Devices, Healthcare, and Hygiene. You will oversee customer quality management, complaint investigations, CAPA, and audits to ensure compliance and continuous improvement.

The role emphasizes strong problem-solving, detailed documentation, and collaboration with cross-functional teams to uphold product quality and customer satisfaction in a global setting.

Qualifications

  • 5+ years of experience in Customer Quality, Quality Engineering, or Quality Assurance within manufacturing or industrial environments.
  • Experience with customers in Medical Devices, Healthcare, Hygiene, Personal Care, or other regulated industries.
  • Proven experience managing customer complaints and leading structured problem-solving activities.
  • Experience supporting and managing customer audits.
  • Experience with change management processes in manufacturing environments.
  • Knowledge of EDANA standards and hygiene industry requirements; familiarity with automotive quality methodologies (APQP/PPAP/MSA/SPC).
  • Strong leadership, communication, and cross-functional collaboration skills.

Responsibilities

  • Serve as the primary quality contact for customers in medical and healthcare sectors and manage quality expectations.
  • Lead investigations of customer complaints using 8D, RCA, and CAPA; prepare corrective actions and responses.
  • Coordinate cross-functional teams to ensure timely issue resolution and verify effectiveness of CAPA actions.
  • Plan, participate in customer audits and maintain audit readiness; manage findings and closure.
  • Drive Change Management activities and maintain QMS documentation in line with customer requirements.
  • Monitor quality KPIs and lead continuous improvement initiatives across products and processes.
  • Promote best practices and maintain relationships with customers to ensure satisfaction.

Skills

8D Problem Solving
Root Cause Analysis
CAPA
FMEA
Statistical Analysis

Education

Bachelor's Degree in Engineering, Quality Management, Materials Science, or related

Tools

APQP
PPAP
MSA
SPC
IATF 16949
ISO 9001

Job description

Mativ Holdings, Inc. is seeking a Senior Quality Engineer to act as the primary quality interface for customers in Medical Devices, Healthcare, and Hygiene. You will oversee customer quality management, complaint investigations, CAPA, and audits to ensure compliance and continuous improvement.

The role emphasizes strong problem-solving, detailed documentation, and collaboration with cross-functional teams to uphold product quality and customer satisfaction in a global setting.

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