Quality Project Manager

The Scherdel group; Muskegon (MI); On-site; USD 85,000 - 110,000; Full time

Job summary

SCHERDEL Medtec North America LLC in Muskegon, MI is seeking a Quality Project Manager to coordinate customer projects and ensure quality throughout the product lifecycle.

You will lead cross-functional teams, manage validation activities (IQ/OQ/PQ), and support audits and continuous improvement in a regulated medical device environment. Domestic/international travel may be required.

Qualifications

• Bachelor's degree in engineering or related field.
• 3+ years in Quality Eng, Quality PM, or Manufacturing Eng.
• Experience in regulated industries (ISO 13485 preferred).
• Proven cross-functional project leadership from launch through production.
• Knowledge of FMEA, CAPA, RCA and Risk Management.
• Strong PM, communication and customer-facing skills.
• Experience with IQ/OQ/PQ qualification/validation.
• PMP/ASQ/Lean Six Sigma is a plus.
• Ability to travel domestically and internationally.

Responsibilities

• Serve as the primary quality contact for customers throughout project execution.
• Lead qualification, validation, and quality planning activities for new product launches.
• Develop, maintain, and train employees on quality procedures and SOPs.
• Support manufacturing teams in maintaining compliance with quality and validation requirements.
• Support the plants in maintaining the validated status.
• Coordinate audits (internal, customer, certification) and drive QMS improvements.
• Lead cross-functional project teams to ensure on-time delivery and quality.
• Identify and mitigate project risks related to quality, timing and customer requirements.
• Support RFQs, feasibility reviews, customer documentation, and project reporting.

Skills

Self-directed

Analytical thinking

Communication/docs

Attention to detail

Multi-client management

Teamwork

Education

Bachelor's degree in Engineering/Quality/Manufacturing/Biomedical Engineering or related field

Tools

FMEA

CAPA

Root Cause Analysis

Risk Management

Job description

START YOUR CAREER IN THE SCHERDEL Family

JOB POSTING

Quality Project Manager
IN MUSKEGON, MI

SCHERDEL Medtec North America LLC., located in Muskegon, MI is a subsidiary of SCHERDEL GmbH, located in Marktredwitz in the state ofBavaria, Germany. We are currently managed by the fourth generation of the founding family withsales and manufacturing activities at 42 sites in various European countries, North and South America and inAsia. SCHERDEL is strongly value driven and has a long track record of caring for our associates in many ways.

Job function:

The Quality Project Manager is responsible for coordinating customer projects within the organization as well as support Operations Quality requirements to meet our Quality Management requirements and objectives.

ESSENTIAL FUNCTIONS:

• Serve as the primary quality contact for customers throughout project execution.
• Lead qualification, validation, and quality planning activities for new product launches.
• Develop, maintain, and train employees on quality procedures and SOPs.
• Support manufacturing teams in maintaining compliance with quality and validation requirements.
• Supporting the production plants in maintaining the validated status.
• Coordinate internal, customer, and certification audits and drive continuous improvement of the Quality Management System.
• Lead cross-functional project teams to ensure successful execution, on-time delivery, and adherence to quality standards.
• Identify and mitigate project risks related to quality, timing, and customer requirements.
• Support RFQs, feasibility reviews, customer documentation, and project reporting while promoting SCHERDEL's capabilities and value proposition.

Position Requirements:

• Bachelor's degree in Engineering, Quality, Manufacturing, Biomedical Engineering, or a related technical field.
• 3+ years of experience in Quality Engineering, Quality Project Management, or Manufacturing Engineering.
• Experience in a regulated industry, preferably Medical Devices (ISO 13485), Healthcare, Pharmaceutical, or Automotive.
• Proven experience leading cross-functional projects from launch through validation and production.
• Knowledge of quality tools and methodologies such as FMEA, CAPA, Root Cause Analysis, and Risk Management.
• Strong project management, communication, and customer-facing skills.
• Experience with qualification and validation activities (IQ/OQ/PQ).
• PMP, ASQ, Lean Six Sigma, or similar certifications are a plus.
• Ability to travel domestically and internationally as required.

SKills

• Self-directed
• Analytical and process-oriented thinking
• Excellent communication and documentation skills
• Excellent eye for detail
• Can manage multiple customers simultaneously, able to prioritize
• Must work well individually as well as in a team environment

Competencies:

• Time Management
• Results Driven
• Problem Solver
• Thoroughness
• Communication
• Personal Effectiveness/ Credibility