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Quality Specialist Post Market

Apply now Job no: 612872
Work type: Permanent
Location: Denver, Colorado, Lone Tree, Colorado
Categories: Quality & Regulatory, North America, Individual Contributor

Quality Specialist, Post Market

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

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.

 

About the role

In order to help Cochlear continue to grow and service our customers, we are recruiting for a Quality Specialist, Post Market in our Americas head office based in Lone Tree, CO.

To be successful in this role you’ll be able to pay attention to detail, have good computer skills, and good communication skills, analysis and problem-solving skills, and work with cross functional teams. You’ll work collaboratively with Quality, Regulatory Affairs, Clinical, and Post Market teams to ensure issues are reported and evaluated for complaints and feedback analysis and ensure compliance in Post Market and Clinical activities. This technical role is responsible for ensuring issues determined through Post Market and Clinical activities are escalated to corporate quality for complaint evaluations, assisting in compliance to post market and clinical documentation and records, as well as collecting, analyzing, and reporting data as appropriate.

Key Responsibilities

  • Collect issues reported during Post Market and Clinical Activities and escalate to corporate quality for complaint evaluation
  • Collect, analyze, and report on issue data
  • Assist in ensuring compliance to regulatory requirements for clinical and post market activities documentation and records
  • Assist in internal and external audits and inspections


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:

  • Strong computer skills, including Microsoft Office and eQMS (prefer Master Control experience)
  • Communication skills, able to communicate effectively with cross functional teams
  • Experience with FDA regulations
  • Experience working in Complaint Handling, Post Market Surveillance, or Clinical Quality

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 internal or external to the organization, utilize problem solving/critical thinking skills to discern and convey information.  May occasionally transport/move up to 25 pounds. Specific vision abilities required by this job include ability to adjust focus.

 

While performing the duties of this job, the individual is regularly required to utilize comprehension, critical thinking, communication, problem solving, organization reasoning, relating to others and discernment of items such as product specifications, procedures and processes to customers (whether internal or external).  Influence, organization of information and planning are also required.


The work environment is an office environment and warehouse environment, and are representative of those an individual encounters while performing the essential functions of this job.

Schedule:

Regular Business Hours, some evenings will be required.

In addition to the opportunity to develop your knowledge and grow professionally, we offer competitive wages and benefits.  The Target Salary Range is $60,000 - $65,000 per year as well as an annual bonus of 4% of base salary.

The overall benefit program includes medical, dental, vision, life and disability, pet insurance, 401K Matching, PTO (vacation, holidays, floating holidays, sick and volunteer time off), tuition reimbursement, transportation supplementation, maternity and paternity leave, and wellness programs.

Apply now by completing your application form online. Applicants must meet the job specific application criteria to be considered. Visit our careers site at www.cochlear.us/careers to learn more.  

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 lawIn 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 303-264-2549.

Advertised: Mountain Daylight Time
Anticpated Application Closing:

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