Quality Assurance Technician – Incoming

Capstan Medical; Santa Cruz (CA); On-site; USD 60,000 - 80,000; Full time

Job summary

Capstan Medical is seeking a Quality Assurance Specialist to support inspections and ensure compliance in the manufacturing of implantable medical devices. This role involves performing visual inspections, supporting quality documentation, and working closely with the Quality Assurance team. Candidates should have a background in medical device manufacturing and familiarity with device history records, making this an impactful opportunity in a cutting-edge medical environment.

Qualifications

• 2-3 years of experience in Class III medical device manufacturing preferred.
• DHR review experience is a plus.
• Experience with structural implant heart devices preferred.

Responsibilities

• Support incoming and production-line Quality inspections for implantable medical devices.
• Execute inspection and test procedures for new products.
• Review Quality records and assist in environmental monitoring.

Skills

Visual Inspection

Data Entry

Quality Records Review

Education

High School Diploma

AA Degree

Job description

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

Reports to: IQC Supervisor

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.

Responsibilities:

• Provide support in incoming and production-line Quality inspections for implantable medical device 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.
• Ability to perform visual inspections (i.e. detect defects) using a microscope and/or magnification visual inspection systems, calipers, etc.
• Ability to read manufacturing prints and identify associated specifications/characteristics related to inspection and testing to be performed
• Ability to use computer and general office software for data entry

Requirements:

• High School graduate; AA degree is a plus
• 2-3 years of experience working in a Class III medical device manufacturing environment is preferred
• DHR (Device History Record) review experience is a plus
• Experience with structural implant heart devices is preferred

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.