Operations Quality Manager
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 an Operations Quality Manager in our Americas head office based in Lone Tree.
In alignment with our organizational principle of providing a safe work environment, and in order to comply with new requirements for contractors of the Federal Government, all US-based employees of Cochlear Americas are required to be fully vaccinated against COVID-19. The only allowable exceptions include qualifying medical and religious accommodations.
To be successful in this role you’ll be able to lead the kitting and drill operations personnel and vendors. You will drive quality and regulatory compliance activities and improvements across all supply chain operations. You’ll work collaboratively with global supply chain operations, vendors, clinical, regulatory, sales and quality/compliance to ensure product compliance and availability. This Manager role is responsible for ensuring compliance, managing kitting and labeling functions, surgical rental equipment process and suppliers, and team development.
- Provide leadership to the Kitting and Surgical rental team with an emphasis on teamwork, performance, and quality. Conduct evaluations and development planning as per company guidelines and processes; lead recruitment, hiring, staffing, and managing performance.
- Follow Quality Management System and applicable medical device regulations to oversee compliance activities for Supply Chain operations as it relates to NCR, CAPA, deviations, complaint investigations, UDI, GTIN, labeling, kitting, and other regulated areas for medical devices and supporting products.
- Manage the surgical rental program by developing and maintaining strong business relationships with key suppliers, overseeing daily program operations, and managing escalations as related to the rental process, equipment, or suppliers.
- Responsible for monitoring and updating policies and procedures to include regulatory or QMS changes; creates and revises procedures, work instructions, and other process-related documentation for Supply Chain operations.
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
- 5 Years of Experience
- Experience with regulated and quality-controlled processes and documentation such as OSHA and FDA procedures and controls.
- Experience in developing and improving processes within an operations or supply chain business environment ensuring quality and regulatory compliance activities.
- Capable of resolving escalated issues arising from operations and requiring coordination with other departments
- Proven track-record managing priorities to tight timelines, balancing multiple tasks with competing deadlines and working effectively with cross-functional teams to meet the needs of the business.
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 and external to the organization, utilize problem solving/critical thinking skills to discern and convey information. Occasionally transport/move up to 50 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/classification of information and planning are also required. The work environment is an warehouse/office environment and are representative of those an individual encounters while performing the essential functions of this job.
Flexibility to work an eight-hour shift between 6:00am-6:00pm, Monday through Friday. In order to best serve our customers, occasional overtime may be required, including Saturday mornings.
In addition to the opportunity to develop your knowledge and grow professionally, we offer competitive wages and benefits. The Target Salary Range is $95,000 - $110,000 as well as a bonus of 12% of base salary.
The overall benefit program includes medical, dental, vision, life and disability, pet insurance, Employee Stock Purchase Plan, 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 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.