Quality Specialist

Entity: Occam-Labs (Capstan Medical + Versa Vascular)

Reports to: Director of Quality

Workplace Type: Onsite

About us:

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 the funky/diverse 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.

Description:

• Support logging and receiving of clinical study complaints and tracking their status to ensure timely resolution.
• Provide support in conducting thorough cross-functional investigations of clinical study complaints, gathering and analyzing data from various sources.
• Provide support in cross-functional assessment of root causes of complaints and impact to product safety.
• Write clear, concise, and technically accurate complaint investigation reports.
• Identify trends and patterns in clinical study complaints and proactively recommend improvements.
• Provide support in production-line Quality inspections for implantable medical devices and/or capital equipment
• Provide support in execution of inspection and/or test procedures to evaluate all aspects of development of new products.
• Provide support in review of Quality records such as Device History Records of product sub-assemblies and/or finished goods.
• Provide support in Quality inspections of supplied medical device components and associated record keeping.
• Assist Quality Assurance team in remedial actions to support disposition of product or component non-conformance
• Assist in environmental monitoring processes and associated record keeping.
• Operate specialized equipment that supports established test and/or cleaning activities.
• Support the development, implementation, and maintenance of quality management systems (QMS).
• Review and maintain quality documentation, CAPAs, and non-conformance reports.
• Investigate and document deviations, root cause analyses, and corrective/preventive actions.
• Provide training on quality standards, procedures, and best practices to employees.
• Ensure compliance with FDA (21 CFR 820), ISO 13485, and other applicable regulatory requirements.

Skills:

• Ability to read manufacturing prints and identify associated specifications/characteristics related to inspection and testing to be performed
• Ability to perform visual inspections (i.e. detect defects) using a microscope and/or magnification visual inspection system
• Ability to use computer and general office software for data entry
• Experience with CAPA, non-conformance investigations, and QMS software.
• Excellent communication and collaboration skills.

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, Quality Assurance, or a related field.
• Minimum of 3 years of professional experience working in a medical device manufacturing environment

Why join us:

• We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space that can make a meaningful impact for patients.
• We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off.
• We thrive in our work-hard, play-hard environment. Bring your bike or running shoes if you’d like or just be ready to enjoy a fun office outing. We enjoy time inside the office and out!

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, veteran status, and disability, or other legally protected status.