Job Description:
Change people's lives and love what you do! Cochlear is the most recognized brand in hearing health care.
Director of Quality, Americas
Position Spotlight:
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Minimum of 10 years of related quality systems work experience in medical device, pharmaceutical or biologics industry.
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Must have working knowledge of FDA regulations and experience communicating and hosting inspections with the FDA and other regulatory agencies.
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Act as a management representative of the QMS (MasterControl)
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 Quality Systems management in the med device, pharma or biologics industries , this is a fantastic opportunity to join the Quality team for the Americas at the global leader in implantable hearing devices! In this role, you will be based in our Americas head office in Lone Tree, CO.
Your success in this role is measured by your ability to ensure QMS processes are enacted, maintained, monitored, and improved. You will also ensure a state of audit readiness and compliance to the relevant regulations.
Key Responsibilities
- Direct the establishment, implementation, and improvement of the QMS processes to ensure compliance with regulatory requirements and enable business practices.
- Ensure a state of audit readiness and compliance to the relevant regulations.
- Serve as Quality business partner and provide guidance and advice to enable the Regional teams to achieve their goals.
- Act as Regional point of contact on Post Market Surveillance and emerging product issues; work closely with key stakeholders including Legal, Manufacturing, and Regional Regulatory, Marketing and Clinical teams.
- Lead a team of other Quality professionals, role modelling a culture of achievement and holding yourself and your team accountable to high performance standards.
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:
- Minimum of 10 years of related quality systems work experience in medical device, pharmaceutical or biologics industry.
- Must have working knowledge of FDA regulations and experience communicating and hosting inspections with the FDA and other regulatory agencies.
- Prefer experience working with manufacturing processes and the FDA from a quality perspective.
- Must be an exceptional communicator, collaborative team member, and positive leader.
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: $175,000 - $185,000 based upon experience, as well as an annual bonus opportunity of 20% of base salary. Exact compensation may vary based on skills, experience, and location.
- 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 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 be asked to occasionally transport/move up to 30 pounds, depending on the position. Specific vision abilities required by this job include ability to adjust focus. 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/classification of information and planning are also required.
The work environment is an office environment and this is representative of those an individual may encounter while performing the essential functions of this job.
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 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 303-264-2549.
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