JOB DESCRIPTION: QA/QC Specialist

General: Full-Time, Exempt Employee Classification: Professional

Reports To: Head of Quality Direct Reports: None

Department: Operations

Location: Onsite preferred (Philomath, OR 97370); 75-80% hybrid optional Schedule/Hours: Monday - Friday, day shift (occasional nights and weekends as production schedule dictates)

Overview of Lazarus 3D: Surgeon skill and experience are the biggest determinants of patient outcomes. Unfortunately, surgeons learn by operating on patients and sometimes they make costly mistakes. Lazarus 3D’s Pre-Sure platform allows surgeons to rehearse every surgery ahead of time on a replica of their patients’ organs. This unparalleled opportunity to exercise their surgical plan on Pre-Sure is game-changing in surgical care as it can transform patient safety and outcomes. Lazarus 3D’s Skill-Sure platform delivers world class solutions to healthcare professionals interested in reducing the learning curve, innovation and adoption of new medical devices. Pre-Sure and Skill-Sure models mimic soft, realistic textures of real organs and provide a unique hands-on operative experience.

Our mission is to help doctors operate with confidence
Lazarus 3D is driven by a singular mission: to enhance patient safety and outcomes through tailored solutions that empower surgeons to operate with unwavering confidence. Our vision is ambitious yet resolute—to eradicate surgical errors, ensuring that every patient receives the best care possible.

Join us at Lazarus 3D as we redefine the boundaries of surgical precision and pave the way for a future where impeccable care is the standard.

Your Role at Lazarus 3D
In this role, you perform QA activities within the Quality System to maintain and/or ensure compliance to governing documents; data entry and basic data analysis, typically from preset forms, or pre-established formats in databases; record review for compliance to governing documents.

Essential Job Functions:

• Supports our vision and mission: To improve patient surgical outcomes.
• Proactively promotes positive culture and commitment to customer success.
• Embrace company core values.
• Comply with Lazarus 3D’s Quality System.
• Perform QC inspection and testing on raw materials, in-process components and final products as dictated.
• Scan and archive documents.
• Review documentation for completeness and accuracy, and compliance to governing documents.
• Investigate and respond to nonconformances, planned deviations and corrective actions as needed
• Work closely with others in the assigned area to recognize opportunities for improvement and drive change through the use of Preventive Actions.
• Perform acceptance activities.
• Perform tasks as assigned by supervisor/manager.

Qualifications and Critical Skills/Expertise:

• 5 years experience with High School diploma OR 2 years experience with Associates degree OR 2 years experience with Bachelor's degree in chemistry, engineering or applicable biological science
• 1 years QA experience, working in a medical device or similarly-regulated industry
• Academic training in basic chemistry, engineering and biology.
• Relevant hands on experience in specific manufacturing processes.
• Experience working under a quality system such as ISO 13485 and or 21 CFR part 820 cGMPs or GLP
• Proficient in the use of Google Suite
• High attention to detail

Other Knowledge and Skills:

• Photography skills (able to photograph models and other products for quality, records of inspection and for use by marketing teams.
• Experience using Qualio a plus
• Basic human anatomy and medical procedures is a plus

Equipment:

• General lab equipment
• Calipers

Working Environment & Physical Requirements:
Approximately 75% of responsibilities are performed in the lab, 25% in an office environment.

While performing the duties of this job, the employee must regularly:

• Experience prolonged sitting, some bending, stooping, and occasional fast walking.
• Use hand-eye coordination and manual dexterity sufficient to operate hand tools.
• Regularly lift and/or move up to 10 pounds, occasionally lift and/or move up to 25 pounds.
• May have exposure to biologics and chemicals.
• Requires close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Applications should be submitted via indeed. The CV and cover letter should be combined into a single document and uploaded to Indeed.

Lazarus 3D is an Equal Opportunity Employer; Employment with Lazarus 3D is governed on the basis of merit, competence and qualifications and will not be influenced in any manner by race, color, religion, gender, national origin/ethnicity, veteran status, disability status, age, sexual orientation, gender identity, marital status, mental or physical disability or any other legally protected status.

Candidates must be US citizens/Permanent residents or be eligible to work in the United States.

Job Type: Full-time

Pay: $45,000.00 - $65,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Experience level:

• 2 years

Schedule:

• Monday to Friday

Work setting:

• Hybrid work

Application Question(s):

• What is your experience working in an FDA regulated or ISO compliant company?

Experience:

• Quality control: 2 years (Preferred)

Work Location: Hybrid remote in Philomath, OR 97370