Quality Engineering Manager - Medical Devices

AirLife; Grand Rapids (MI); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k)

Paid time off

Job summary

AirLife in Grand Rapids, MI is seeking a Quality Engineering Associate Manager to lead quality assurance activities for product design and regulatory compliance. This leader will supervise a team of quality professionals and coordinate with R&D, manufacturing, and other functions.

Responsibilities include driving continuous improvement, managing KPIs, and ensuring adherence to ISO 13485 and FDA requirements while promoting a culture of accountability and strong supplier and customer focus.

Qualifications

• Minimum 5 years in Quality or Design Engineering roles or leadership in FDA-regulated and/or ISO-certified environment (preferably Medical Device, ISO 13485).
• Bachelor's degree in engineering is required.
• Knowledge of ISO 13485, Design Controls, Risk Management, Root Cause Analysis, and Complaint Handling / Post Market Feedback.

Responsibilities

• Line Manager duties: provide direction, coaching, and performance management to the quality team; align objectives with AirLife priorities; participate in recruitment and disciplinary processes; drive continuous improvement; promote engagement, inclusion, and career development; manage budget.
• Individual Contributor duties: champion customer focus; lead a team of quality engineers; ensure urgency and decision-making; promote collaboration and quality across functions; oversee quality systems and audits.
• Cross-functional collaboration: work with R&D, marketing, manufacturing, supply chain, and QA to share feedback and drive product quality improvements.

Skills

Quality Leadership

Cross-functional collaboration

Regulatory knowledge

Root Cause Analysis

Project management

Mentoring team

Data analysis

Communication

Microsoft Office

Decision making under pressure

Education

Bachelor's degree in engineering

Job description

AirLife in Grand Rapids, MI is seeking a Quality Engineering Associate Manager to lead quality assurance activities for product design and regulatory compliance. This leader will supervise a team of quality professionals and coordinate with R&D, manufacturing, and other functions.

Responsibilities include driving continuous improvement, managing KPIs, and ensuring adherence to ISO 13485 and FDA requirements while promoting a culture of accountability and strong supplier and customer focus.