Director Quality Operations

Inogen • Plano, TX

2d • $167,000 - $208,000 • Onsite

About The Position

The Director Quality Operations is a critical leadership role responsible for Quality Operations activities and team to achieve product quality, compliance, and business objectives
This position requires expertise in Quality Operations, Quality Engineering, and medical device regulations. This position operates in a fast paced and cross functional team environment. This position requires the ability to operate proficiently in strategic and hands on tactical levels.
The position reports to the EVP, Chief Quality and Regulatory Officer and is located onsite at the Inogen facility in Plano TX.

Requirements

• Demonstrated knowledge of global medical device regulations such as EU MDR, FDA, etc.
• Demonstrated expertise in Quality Operations such as statistics, risk management, sampling plans, KPI’s, supplier quality, device inspections, validation, calibration, audits, etc.
• Must have excellent communication, presentation and influencing skills.
• Ability to develop and maintain highly effective cross functional relationships
• Must be highly collaborative and thrive in a team environment
• Demonstrated leadership skills with the ability to mentor and develop teams.
• Excellent data driven problem-solving, organizational, and written and verbal communication skills
• Hands-on skills such as procedure review/development, approval and implementation.
• Ability to effectively collaborate on and lead the deployment of strategic objectives
• Bachelor's Science degree required, with BS in Engineering strongly preferred
• Proven track record of compliance to global medical device regulations such as EU MDR, US FDA, and achieving quality manufacturing related business objectives.
• Minimum 10 years of progressive experience in medical device manufacturing quality activities such as device inspections, product release, quality engineering, CAPA, metrology, audits, and supplier quality at international medical device companies with a minimum annual revenue of $500M USD.
• Minimum 5 years in a people manager role with demonstrated people management responsibilities within the quality organization and medical device industry.
• Demonstrated experience leading a company through FDA inspections. Must have personally served as the primary host or lead during at least one FDA inspection.

Responsibilities

• Lead and manage Quality Operations personal and activities such as product inspection and release, NCMR, SCAR, CAPA, calibration, process/test method validation, design transfer, supplier controls.
• Ensure product quality, compliance, and business objectives are achieved
• Establish, monitor, and achieve KPIs, taking prompt action when necessary
• Collaborate on business planning and maintain costs within budget constraints.
• Build and maintain strong relationships with internal and external stakeholders.
• Manage and develop Quality manufacturing team
• Support design, manufacturing, and continuous improvement related projects
• Participate in internal and external audits leading to successful outcomes
• Participate in cross functional teams in support of business objectives
• Support complaint investigations
• Support supplier qualification, selection, monitoring, and improvement activities

Benefits

• In addition to the expected base salary, this role is eligible to participate in Inogen’s annual performance bonus incentive plan, highly competitive and company-sponsored benefits, and wellbeing programs rooted in our strong culture of excellence.
• As a valued member of our team, Inogen provides health, dental, and vision insurance, 401(k) plan plus employer contribution and match, and generous paid leaves such as vacation and sick leave, including paid volunteer time, that can support you and your family through moments that matter.

What This Job Offers

• Job Type: Full-time
• Career Level: Director