Quality Engineering Lead – Medical Devices

Sunmed Llc; Grand Rapids (MI); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) plan

Paid time off

Paid holidays

Bereavement leave

Employee Assistance Program

Job summary

AirLife in Grand Rapids, MI is seeking an Associate Manager, Quality Engineering to lead a team responsible for product design quality, regulatory compliance, and continuous improvement across AirLife’s portfolio. The role requires a bachelor’s degree in engineering, 5+ years in quality or design engineering within FDA/ISO environments, and 10–15% travel.

You will partner with R&D, manufacturing, and supply chain to drive root-cause analysis, KPI reporting, and timely corrective actions while

Qualifications

• Knowledge of ISO-13485 and Design Controls.
• Strong communication and cross-functional collaboration.
• Leadership and mentoring of technical teams.

Responsibilities

• Provide direction and coaching to team; manage performance.
• Align team objectives with priorities; ensure regulatory compliance.
• Lead recruitment and disciplinary processes.
• Drive continuous improvement and best practices.
• Promote employee engagement and career development.
• Manage team budget and financial accountability.
• Represent customer needs to AirLife internally.
• Lead a team of quality engineers and SMEs.
• Act with urgency and bias for action in QA.
• Mentor and empower the team; provide feedback.
• Own QA processes for audits/inspections and SOPs.
• Drive KPIs and reporting for visibility.
• Identify and prioritize improvement initiatives.
• Collaborate cross-functionally with R&D, marketing, manufacturing, supply chain.

Skills

Interpersonal skills

Verbal communication

Written communication

Cross-functional collaboration

Prioritizing projects

Mentoring teams

Quality control standards

Analytical problem solving

KPI driven acumen

Microsoft Office

Process improvement

Decision making under pressure

Data analysis

Root cause analysis

Education

Bachelor’s degree in engineering

Tools

Microsoft Office

Job description

AirLife in Grand Rapids, MI is seeking an Associate Manager, Quality Engineering to lead a team responsible for product design quality, regulatory compliance, and continuous improvement across AirLife’s portfolio. The role requires a bachelor’s degree in engineering, 5+ years in quality or design engineering within FDA/ISO environments, and 10–15% travel.

You will partner with R&D, manufacturing, and supply chain to drive root-cause analysis, KPI reporting, and timely corrective actions while