QA/QC Manager

Type of Position: Full-time, exempt

Department: Quality

Reports To: COO

Direct Reports: QA/QC Specialists, QC Technicians

Location: Onsite (Philomath, OR)

Schedule/Hours: Monday-Friday, 8:00 AM -

4:30 PM (occasionally 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 hands-on skills 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 patient created in hyper realistic materials. This technology has the potential to transform patient safety and outcomes. Lazarus 3D’s Skill-Sure platform delivers world class surgical training solutions to healthcare professionals, reducing the learning curve, aiding development of innovative solutions, and is used by medical device companies for training, demonstration and marketing. Pre-Sure and Skill-Sure models mimic the 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 eliminate surgical errors. Our technology helps doctors Operate with Confidence. Join us at Lazarus 3D as we define a new era of surgical precision and personalized care.

Your Role at Lazarus 3D:

In this role, you are responsible for developing and maintaining a quality program for the organization that provides an infrastructure that meets or exceeds industry standards and regulations, under the oversight of Executive Management. You will also develop and present reports on data/trending to management (i.e., Management Review), perform Product Release and be part of the external inspection team. You will participate in planning and managing activities to meet annual Quality Objectives, ensure Quality System and Quality Manual conforms to regulatory requirements and standards, manage all quality functions and coordinate QC and QA activities to achieve corporate goals.

Essential Job Functions:

• Support our vision and mission: To improve patient surgical outcomes.
• Proactively promotes positive culture and commitment to customer success.
• Comply with Lazarus 3D’s Quality System.
• Perform tasks as assigned by supervisor/manager.
• Embrace company core values.
• Perform QC inspection and testing on raw materials, in-process components and final products as dictated.
• Responsible for ensuring the Quality Manual is accurate and current to reflect Lazarus 3D’s system, and is compliant to standards and regulations (including the Safety Program)
• Oversight and management
• Provide oversight for project budgets and monitors expenditures, and optimizes allocated department resources.
• Work with suppliers and contracted organizations to meet Quality objectives within the scope of the service or materials being supplied to Lazarus 3D
• Remove barriers to successful implementation and works to resolve them
• Responsible for overall organization, development, direction, coordination and evaluation of the QA team members.
• Improvement and Trend analysis
• Reviews metrics provided by QA staff, and provides metrics to demonstrate functionality of the Quality System(s) of responsibility on a routine basis to Executive Management and area Managers
• Performs analysis and suggests potential solutions to correct and/or prevent issues from recurring
• Identifies possible changes to improve efficiency and consistency
• May be the designated Management Representative
• Training and Coaching
• Provides company training on compliance topics and ensure organization stays current with industry expectations on common practices
• As a consultant to company employees to provide guidance on how to meet requirements of Lazarus 3D’s Quality System
• Promotes logical approach to quality to encourage individual, self-driven compliance, excellence and effectiveness
• Provides strong leadership, mentoring, coaching, counseling and development to staff members.
• Works with leadership to drive culture and change.
• Continuous professional growth and on-going compliance
• Stays current with industry expectations on commons practices through third-party training and/or reading of publications (such as guidance documents)
• Participates on Design Control project team
• May manage projects to achieve corporate goals and objectives
• Performs activities to meet the production schedule, project timelines and as defined by the Quality System

Qualifications and Critical Skills/Expertise:

• 10 years with BS degree in chemistry, engineering or applicable biological science OR 5 years with MS degree in chemistry, engineering or applicable biological science AND 1 years leading projects or supervisory experience
• 3 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
• Prior experience supervising lab techs, engineers, scientists, senior scientists, project managers
• 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

Required Familiarity with the following 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.

The CV and cover letter should be combined into a single document and uploaded to really.

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: $72,800.00 - $135,200.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off

Schedule:

• Monday to Friday
• Weekends as needed

Experience:

• QA: 3 years (Required)

Ability to Commute:

• Philomath, OR 97370 (Required)

Ability to Relocate:

• Philomath, OR 97370: Relocate before starting work (Required)

Work Location: In person

Salary : $72,800 - $135,200