Senior Manager, Clinical Quality and Compliance - QA

Change people’s lives and love what you do! Cochlear is the most recognized brand in hearing health care.

Senior Clinical Quality and Compliance, Manager – Quality Assurance

Position Spotlight:

• Contributing or leading to relevant quality or performance activities such as metrics, auditing, CAPA root cause or effectiveness monitoring, QMS implementation or transition planning
• Development of audit and inspection-readiness procedures, templates, and reporting tools.
• Scheduling and conduct of clinical investigation audits for Cochlear-sponsored studies.
• Conduct of activities that support quality oversight and inspection readiness for all clinical affairs and operations functions.
• Lone Tree, CO/Hybrid

Change people’s lives and love what you do!  Cochlear is the most recognized brand in hearing health care.

About the role

Cochlear is helping people hear, and be heard, all over the world. Come be a part of our amazing mission! If you are proficient at collaborating with stakeholders, subject matter experts, and CQC resources to develop and deliver integrated quality assurance activities for clinical investigations worldwide, this is a fantastic opportunity to join the Clinical Operations team at the global leader in implantable hearing devices! In this role, you will be office based, hybrid role, located in Lone Tree, CO.

Your success in this role is measured by your ability to advance CQC objectives, ensuring alignment with relevant local regulations. Work collaboratively with internal stakeholders including CSI executive leadership, functional leads, process owners to identify and deliver quality metrics.

Key Responsibilities

• Development of audit and inspection-readiness procedures, templates, and reporting tools.
• Identification and onboarding of qualified consultant auditors.
• Scheduling and conduct of clinical investigation audits for Cochlear-sponsored studies.
• Conduct of activities that support quality oversight and inspection readiness for all clinical affairs and operations functions.
• Conduct of site and vendor audits as required to support regulatory and GCP compliance, inspection readiness or issue management.

Key Requirements

To add value to Cochlear in this role you'll be able to meet and demonstrate the following knowledge, skills and abilities in your application and at interview:

• Contributing or leading to relevant quality or performance activities such as metrics, auditing, CAPA root cause or effectiveness monitoring, QMS implementation or transition planning
• Working knowledge and experience in practical application of Good Clinical Practice principles and relevant Code of Federal Regulations
• Experience developing quality management documentation such as standard operating procedures and CAPA
• Excellent communication and interpersonal skills, with the ability to bring together groups with diverse needs and viewpoints while still achieving objectives and timelines
• Ability to work effectively independently and in a team setting with the ability to influence without authority

Total Rewards

In addition to the opportunity to develop your knowledge and grow professionally, we offer competitive wages and benefits.

• Pay Range in the United States: $155,000 - $165,000, based upon experience. Exact compensation may vary based on skills, experience, and location.

Who are we?

Human needs have always been our inspiration, ever since Professor Graeme Clark set out to create the first multi-channel cochlear implant because he saw his father struggle with hearing loss. We always start with people in mind – thinking about their needs.

For this reason, our products, services and support will continue to evolve and improve. We are by our customers’ side through the entire hearing journey, so they can experience a life full of hearing. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives and working in an organization where they can be part of bringing the mission to life each day.

Physical & Mental Demands

The physical and mental demands described below are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the individual is regularly required to be in a stationary (seated/standing) position; utilize business technology for work product delivery, communicate orally and in writing with others in