Associate Manager, Quality Engineering

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

Company Description

At AirLife, we are dedicated to improving the quality of every breath. Excellence with Every Breath is not just a tag line, but the way we work and take care of our customers. With a mindset to evolve, innovate, and grow, we are a premier manufacturer of the highest-quality and market-leading breathing consumables. This growth philosophy has positioned us to increase our global footprint and business reach, impacting even more people around the world. Our expanding family of the most trusted brands offers a product portfolio that spans the continuum of care from first responder to home care, with safety, patient comfort, and clinical performance in mind. Collective expertise allows us to provide quality products and experiences to our patients, customers, and our people. Our values of Customer first, Differentiate with our People, Bias for Action, Continuous Improvement and Accountability define who we are and how we work.

Company Description

At AirLife, we are dedicated to improving the quality of every breath. Excellence with Every Breath is not just a tag line, but the way we work and take care of our customers. With a mindset to evolve, innovate, and grow, we are a premier manufacturer of the highest-quality and market-leading breathing consumables. This growth philosophy has positioned us to increase our global footprint and business reach, impacting even more people around the world. Our expanding family of the most trusted brands offers a product portfolio that spans the continuum of care from first responder to home care, with safety, patient comfort, and clinical performance in mind. Collective expertise allows us to provide quality products and experiences to our patients, customers, and our people. Our values of Customer first, Differentiate with our People, Bias for Action, Continuous Improvement and Accountability define who we are and how we work.

Position Summary

A Quality Engineering Associate Manager leads activities for quality assurance of product design, by ensuring the regulatory and quality processes for compliance are adhered to. This position is a leader who is responsible for overseeing a group of quality professionals, providing direction on daily activities surrounding sustainment, post market feedback, and continuous improvement. In this role, the leader is expected to partner with cross functional departments to ensure priorities are aligned and to drive communication on opportunities for product development.

Position Qualifications

The specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance. These competencies are generally demonstrated through specific service, education, or training.

Knowledge

• ISO-13485
• Design Controls
• Risk Management
• Root Cause Analysis
• Complaint Handling / Post Market Feedback

Skills

• Strong interpersonal skills, including effective verbal and written communication.
• Ability to interact effectively with functions of a global organization to achieve goals.
• Demonstrated ability in prioritizing and completing projects with cross-functional teams.
• Ability to mentor and lead technically competent teams.
• Thorough understanding of quality control standards and methodologies.
• Analytical problem-solving skills.
• Demonstrated objectivity and KPI driven acumen.
• Proficient with Microsoft Office Suite or related software.
• Passion for exploring new and groundbreaking processes.
• Ability to make informed decisions under pressure.
• Ability to monitor and analyze complaint data and leading root cause corrective actions.

Level Of Experience

• A minimum of 5 years in Quality or Design Engineering roles or Leadership with experience in an FDA regulated and/or ISO certified organization (preferably Medical Device, ISO 13485).

Level Of Education

• Minimum of a bachelor’s degree in engineering

Travel

• 10-15% Travel Expected; ~2-3 trips per year.

Essential Duties And Responsibilities

Line Manager Duties

• Provide clear direction, coaching, and performance management to support team development and achievement of AirLife goals.
• Align team’s objectives with AirLife priorities, ensuring compliance, promoting a culture of accountability, and upholding AirLife values.
• Take accountability and ownership for actively participating in recruitment processes and supporting fair treatment in disciplinary processes for your team.
• Drive continuous improvement by fostering innovation, operational excellence, and adoption of best practices within the team.
• Champion employee engagement, inclusion, and career development through regular check-ins, talent reviews, and succession planning.
• Manage your team’s budget responsibly and exhibit financial accountability.

Individual Contributor Duties

• Customer First: Represent the customer internally to AirLife for product and service opportunities. Seek to understand customer feedback and ensure responsiveness and service is provided.
• Leadership: Lead a small team of quality engineers focused on a subset of the AirLife product portfolio or a team of subject matter experts of product quality processes. Provide mentorship and direction to the team to include performance feedback and management.
• Accountability: Represent quality assurance for AirLife and the customer with a sense of urgency and a bias for action. Demonstrate the ability to make decisions and set clear direction.
• Engagement: Lead, mentor, and empower a team of quality engineers and technical specialists, promoting a collaborative and high-performance culture that focuses on quality, innovation, and collaboration.
• Compliance: Ensure processes are conducted for product quality in accordance with regulatory requirements and in compliance with the AirLife quality management system. Own related quality system SOPs and serve as process SME in audits / inspections.
• Deliver Results: Drive key performance indicators (KPIs), establishing processes for monitoring, and reporting mechanisms for organizational visibility and awareness.
• Continuous Improvement: Identify and prioritize continuous improvement initiatives for design and manufacturing, partnering with cross functional departments and using data to drive areas of focus.
• Cross-Functional Collaboration: Work closely with R&D, marketing, manufacturing, supply chain, and quality assurance teams to share customer feedback, influence improvements, and achieve positive outcomes for projects.

Other Responsibilities

• Focus on achieving our Company mission.
• Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.
• Inspire the trust of others; treat people with respect and dignity and embrace the value of diversity.
• Use time efficiently; perform job accurately, thoroughly, and conserve Company resources to improve profits.
• Contribute to building and maintaining a positive team environment.
• Assure all policies and guidelines are implemented and followed.

QUALITY POLICY

At AirLife, Quality is our promise. It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market. This promise is kept through a continuously improving and effective Quality Management System and compliance to Regulatory Requirements.

DEIA STATEMENT

At AirLife, we are committed to building a diverse workforce and an inclusive workplace that reflects the communities and customers we serve. We believe our philosophy on Diversity, Equity, Inclusion, and Advancement (DEIA) encourages excellence and equips us to serve an evolving global marketplace.

Benefits

AirLife offers a comprehensive benefits package, including medical, dental, and vision coverage, 401(k), paid time off, paid holidays, bereavement leave, Employee Assistance Program resources, and medical leave benefits, subject to applicable eligibility requirements. Certain positions may also be eligible for bonus, commission, or other incentive compensation.