Quality Director (CAM)
Job no: 612059
Work type: Permanent
Location: Denver, Colorado
Categories: North America, Manager of Managers
Job Title: Quality Director
Change people’s lives and love what you do! Cochlear develops world-leading medical devices that help people hear. As a top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded cochlear implant system than any other.
Do you have 10 or more years of experience working with quality systems in the medical device, pharmaceutical or biologics industry? Do you possess a deep understanding of FDA regulations? Have you managed a team and provided solid leadership, building team capability by coaching for growth and success?
With continued growth on the horizon, Cochlear is hiring for a Quality Director for our Americas region, headquartered in Lone Tree, Colorado.
In this role, you will actively promote the quality management system and ensure all staff are trained so that everyone delivers the highest quality products and service. You will act as the local point of escalation for quality personnel to ensure day-to-day issues are managed and resolved. You will maintain the site’s readiness for external audits at all times which should result in zero major non-conformances by ensuring the successful execution of an internal audit program to identify and correct potential non-conformances.
This role is part of a global team with local responsibilities. You will engage with site senior leaders to drive quality integration across key areas of the business. You will help direct the implementation and continuous improvement of the Quality Management System. This is a unique opportunity to join a Quality team with a mission-driven, global organization.
To add value to Cochlear in this role you'll be able to demonstrate the following skills and experience in your application and at interview:
- Bachelors degree in science, Engineering or related discipline
- Minimum 10 years of related quality systems work experience in medical device, implantable technology preferred, pharmaceutical or biologics industry
- Excellent working knowledge of FDA regulations, QSR, ISO13485, EU-MDR
- Demonstrated proficiency in quality systems and strong overall technical skills
- Strong communication, planning, organisational and team skills, including training/presentation and project management skills
- Experience managing and developing others
Apply now by completing your application form online. Cochlear is an equal employment opportunity organization. Applicants must meet the minimum job specific application criteria to be considered.
Cochlear Americas is an Equal Opportunity, Affirmative Action Employer and provides equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, marital status, veteran status, or any other characteristic protected by federal, state or local law. In addition, Cochlear will provide reasonable accommodations for qualified individuals with disabilities. If you require accommodation with completing the online application, please contact us via web or phone at 303-264-2349.
Visit our careers site at www.cochlear.us/careers to learn more about current openings!
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