Enable America Jobs

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

Senior Quality Specialist (Internal title: Regional Senior Quality Specialist)

• Deadline to apply: June 25, 2024

Position Spotlight:

• 3+ years of medical device quality experience with knowledge of FDA regulations and ISO 13485
• Hybrid work environment consisting of two days in office and three days remote work from home once approved by manager
• Maintenance and improvement of the QMS through a variety of Quality-related activities

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 know ISO 13485 and have experience working with Quality Management Systems within a highly regulated environment, this is a fantastic opportunity to join the Quality team at the global leader in implantable hearing devices! In this role, you will be based in our Americas head office based in Lone Tree, CO.

The Regional Senior Quality Specialist has the responsibility of contributing to the maintenance and improvement of the QMS through managing the Non-conformances program, conduct internal audits, specialize in processes enabling distribution of medical devices and participate in activities to ensure compliance with applicable medical device regulations and standards. You will join a team of dedicated co-workers engaged in the establishment, assessment and continuously improvement of the Quality Management System. You'll work collaboratively within global quality and with regional partners to enable business departments to enact their QMS processes.

Key Responsibilities

• Enacts processes for the document and records management system, as well as the change control, training, internal audit and management review processes
• Facilitates difficult root cause analysis activities and supports the identification, evaluation and implementation of corrective actions, for non-conformances across the region.
• Enables business growth through influencing process design to ensure regulatory requirements are met through policies, practices and procedures.
• Lead improvement projects across the region, both within the quality team and cross functionally.
• Participate in delivering the QMS training program for the region. Design and deliver quality training as required.

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:

• Bachelor's Degree or Equivalent Work Experience
• 3+ years of medical device quality experience in a medical device or life sciences technology company.
• Experience in ISO 13485 and specific regional requirements (EU MDR Quality System Requirements, etc.).
• Knowledge of continuous improvement methodology and process control techniques and experience with implementation of processes, systems and reporting tools
• Experience with operational quality in a sales and distribution environment

Salary and Benefits

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

• Target Salary Range in the United States: $82,000 - $90,000 based upon experience, as well as an annual bonus opportunity of 7.5% of base salary. Compensation offered to candidate may vary based on work experience, education and/or skill level.
• Benefit package includes medical, dental, vision, life and disability insurance as well as 401(K) matching with immediate vesting, Paid Time Off, tuition reimbursement, maternity and paternity leave, Employee Stock Purchase Plan and pet insurance.

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