Associate Manager, Quality Engineering

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Associate Manager, Quality Engineering

Full Time Grand Rapids, Grand Rapids, MI, US

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

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

• 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.
• 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.