Description
Job Summary
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.
Responsibilities (Specific Tasks, Duties, Essential Functions Of The Job)
- 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
Knowledge, Skills, And Abilities
- 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
Qualifications (Experience And Education)
- 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.
Disclaimer
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
Inogen assesses market data to ensure a competitive compensation package for our employees. The base salary for this position is expected to be between $167,000.00 and $208,000.00 annually. However, actual base salary if hired will be determined on an individualized basis and will be based on non-discriminatory factors, including as to individual skills, education, experience and market location.
Our Benefits and Rewards:
In addition to the expected base salary, this role is eligible to participate inInogen’sannual performance bonus incentive plan,highly competitiveand company-sponsored benefits, and wellbeing programs rooted in our strong culture of excellence. As a valued member of our team, Inogen provideshealth, dental, and vision insurance, 401(k) plan plus employer contribution and match, andgenerous paid leaves such as vacation and sick leave, including paid volunteer time, that can support you and your family through moments that matter.
Inogen is an Equal Employment Opportunity/Affirmative Action Employer - Underrepresented racial and ethnic groups/Females/Individuals with Disabilities/Protected Veterans.
