Associate Manager, Quality Engineering
AirLife
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.
Job description
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.
- Represent the customer internally to AirLife for product and service opportunities.
- 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.
- Represent quality assurance for AirLife and the customer with a sense of urgency and a bias for action.
- Lead, mentor, and empower a team of quality engineers and technical specialists, promoting a collaborative and high-performance culture.
- 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.
- Drive key performance indicators (KPIs), establishing processes for monitoring, and reporting mechanisms for organizational visibility and awareness.
- Identify and prioritize continuous improvement initiatives for design and manufacturing, partnering with cross functional departments and using data to drive areas of focus.
- 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.
Requirements
- ISO-13485
- Design Controls
- Risk Management
- Root Cause Analysis
- Complaint Handling / Post Market Feedback
- 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
- 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)
- Minimum of a bachelor's degree in engineering
- 10-15% Travel Expected; ~2-3 trips per year
Benefits
- Medical Coverage
- Dental Coverage
- Vision Coverage
- 401(k)
- Paid Time Off
- Paid Holidays
- Bereavement Leave
- Employee Assistance Program
- Medical Leave Benefits
Company overview
AirLife is a medical equipment manufacturing company specializing in respiratory care and critical care products. The company focuses on developing and manufacturing innovative medical devices for respiratory therapy, oxygen delivery, and patient monitoring systems. AirLife's product portfolio typically includes respiratory circuits, oxygen masks, nebulizers, and other essential equipment used in hospital settings, home healthcare, and emergency medical services. As a medical device manufacturer, AirLife plays a crucial role in supporting respiratory care across various healthcare environments, from intensive care units to outpatient facilities. The company's commitment to quality and innovation in respiratory technology helps healthcare providers deliver effective treatment to patients with respiratory conditions, contributing to improved patient outcomes and enhanced clinical workflows in respiratory care management.