Auris Health, Inc. is recruiting for a Change Control Supervisor. This position will be located in Redwood City, CA.
Auris Health, Inc., part of the Johnson & Johnson family of companies, is transforming medical intervention. By combining advancements in medical robotics, instrumentation, navigation and data science, Auris is building a platform technology capable of expanding the applicability of robotics to a spectrum of medical procedures. Learn more about Auris Health at https://www.aurishealth.com/.
The Change Control Supervisor is responsible for supervising the team that oversees the document and engineering change control processes and maintains the design history files for all AURIS medical devices. This is a hands-on role and this individual will process change orders in support of the team, give guidance to change owners and coordinate process improvements. AURIS is a face-paced environment and the Document Control team supports multiple interdisciplinary teams that will demand exceptional support, thoroughness and attention to detail, excellent verbal and written communication in addition to efficient execution. The successful candidate will be familiar with US FDA regulations for medical devices (cGMP, GCP) and ISO 13485.
Core Job Responsibilities:
- Provides leadership for the Document Control team and related projects
- Ensures that work is allocated and managed for a high level of accountability and efficient execution
- Processes Document Change Orders and Engineering Change Orders in support of compliance, quality management systems, manufacturing organization, project delivery teams, etc.
- Coordinates the training for document and engineering control for the organization.
- Provide guidance to document and engineering change initiators
- Maintains awareness of all project document control requirements and proactively works with the responsible Project Managers to ensure that document control procedures are consistently followed
- Ensures that all product development project deliverables are tracked, and the electronic design history file is maintained properly
- Support creation and maintenance of BOMs, part specifications, and manufacturing drawings and instructions.
- Implements improvement strategies with the objective of optimizing work processes for greater efficiency and quality of work
- Works with the Agile Subject Matter Expert "SME" to implement improvements or facilitate integration with other business software solutions
- Capable of working with limited supervision
Other Job Responsibilities:
- Gather and publish metrics for management review.
- Participate in internal and external audits.
- Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
- A minimum of a Bachelor’s Degree or equivalent required
- A minimum of six (6) years of document control experience in an engineering or project delivery environment required
- A minimum of two (2) years in a supervisory role required
- A minimum of five (5) years' experience in a regulated environment required, Medical Device industry experience preferred
- Knowledge of document control systems and software required, experience with Agile PLM document control systems desirable
- Superior time management, ability to multi-task with a commitment to complete, & timely work required
- Excellent oral and written communication skills required
- Demonstrated ability to assist in the training of other personnel in the use of document control systems and software required
- Ability to recognize problems, recommend solutions, and put the solutions into action required
- Strong skillset in Microsoft Office Suite and advanced skills in MS Word and MS Excel required in order to assist in formatting & compilation of documents
- Excellent supervisory skills with the ability to manage multiple priorities by effective coordination of department resources required
- This position may require up to 10% of domestic travel
Johnson & Johnson is an Affirmative Action
and Equal Opportunity Employer.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-California-Redwood City-
Auris Health, Inc. (6267)