Title: Document Control Specialist
Type: Onsite/Hybrid
This role is for the Occam Quality Assurance shared services for Capstan and Versa.
Description:
- Manage document workflows within the electronic document control system (Propel)
- Track and support change orders from creation through release
- Create and execute training programs and maintain training records for all employees
- Participate in document control improvement activities i.e. updating SOPs, forms, and templates
- Support internal and external audits, including preparation of documentation, participation in audits, and implementation of audit findings
- Other quality responsibilities may include managing external standards, summarizing quality system process metrics,
Skills:
- Proficiency with Microsoft Office applications
- Strong communication skills
- Ability to prioritize and organize work independently.
- Attention to detail
- Demonstrate initiative, a collaborative orientation, and strong communication skills
Requirements:
- BA/BS with 3+ years work experience in a regulated healthcare industry segment (medical device, biopharma, diagnostics) in a document control or quality role
- Experience with following quality processes governed by regulatory standards i.e. 21CFR820 and ISO 13485
- Excellent organizational and time management skills
- Experience with key systems such as Microsoft Office and ePLM/eQMS systems and the ability to manage documents within relevant systems
- Experience using Propel eQMS is preferred
- Flexible and comfortable in a fast-paced work environment.
Overview
Occam Labs is an engineering incubator targeting early-stage medical device design. We focus on cultivating cutting edge technology centered on patient value. Our team is highly collaborative and hands-on, takes pride in iterating quickly, and believes that the best ideas can come from anywhere or any person! We always have multiple programs in the pipeline so, as a small team, we tend to wear multiple hats on a daily basis.
Occam Labs is uniquely positioned in Santa Cruz, which we have chosen to be geographically close-to but intentionally separate from the greater SF Bay Area. This gives us access to the amazing technical talent of the bay area but in an environment that we feel is conducive to doing our best creative work. Our office is located in a repurposed warehouse space that used to be the Wrigley Gum factory, now home to several bicycle companies, many art and architecture studios, a maker space, and several biotech startups. It is adjacent to large tracts of open space with bicycle trails straight from the office doors offering access to the hills and beaches of Wilder Ranch State Park for road/mountain bicycle riding, hiking, and surfing.
Currently, our active programs at Occam Labs target catheter-based repair devices for diseases that affect the heart. These kinds of devices present patients with compelling, minimally invasive alternatives to traditional surgical methods. For most patients, this means less pain after surgery and being able to return to normal life much more quickly. For many older patients, reducing surgical trauma can make the difference between life and death. Our current strength is in micro-scale mechanical medical devices on the cutting edge of medicine but we are constantly evolving. The team has a collective background designing a wide variety of medical devices including cardiac devices, catheter-based devices, collapsible implants, surgical tools and robotic systems.