Quality Engineer

About the Organization

By joining the Instant Systems team, you will be at the forefront of innovation in med tech and biotechnology. You will work with innovative companies who are leading the way in creating lifesaving therapies for patients around the world. You will work side by side with your fellow team members to create future innovations for best patient outcomes. We are looking for strategic problem solvers who thrive in an autonomous environment of diverse and energized collaborators.

If you are motivated by new challenges and opportunities for skills growth, we welcome you to apply. Your energy and expertise is valuable, spend it making a difference on a worthy mission.

We are seeking a highly motivated, hands on and detail-oriented Quality Engineer to join our team. This role is responsible for developing, optimizing, and maintaining manufacturing processes to ensure high-quality production of single use supplies including medical device components. The ideal candidate will have hands‑on experience in a manufacturing environment, with a strong background in process engineering, lean manufacturing, and quality systems within a regulated industry.

• Knowledge and experience with quality tools, such as CAPA, six sigma, lean manufacturing, PPAP, FMEA, problem solving techniques, and root cause analysis.
• Participate in APQP and NPI activities
• Lead, document, and track FMEAs
• Responsible for coordinating suppliers and verifying quality standards in accordance with industry and customer requirements
• Develop and implement supplier management programs
• Identify technical problems as well as cost reductions with suppliers
• Manage Supplier corrective actions
• Provide quality support in all aspects of the Product Life Cycle (design & development, qualification, testing, release to production and release to customer)
• Conduct quality investigations (CAPA and NCR) and Material Review Board (MRB)
• Coordinates activities between cross‑functional teams in support of FRACAS (Failure Reporting and Corrective Action System).
• Drives root cause corrective actions (RCCA) for quality issues
• Utilizes and implements systematic RCCA and Six Sigma methods, tools, and techniques.
• Supports 3rd party, customer, internal and external audits
• Supports inspection and ensures compliance of engineering (formal and dry run) verification, acceptance, and qualification tests
• Define Quality Standards, Identify Critical to Quality (CTQ) requirements and apply Key Process Indicators
• Develops Quality Assurance Plans with the participation of cross‑functional teams.
• Position requires allocation of varied assignments, projects, challenges and other tasks as assigned.
• Authors validation protocols and reports

• Ability to write reports, business correspondence, and create project plans.
• Ability to effectively present information and respond to questions from the customer and/or management.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.

• Bachelor’s Degree and minimum 4 years of prior relevant experience. Graduate Degree and a minimum of 2 years of prior related experience. In lieu of a degree, minimum of 8 years of prior related experience.
• Knowledge of plastic materials a plus
• Practitioner of scientific method
• Proficient knowledge of ISO based Quality Management Systems.
• Mechanical engineering experience preferred
• Knowledge of Quality Engineering and Advanced Quality principles (Six Sigma methodology, Root Cause/Corrective Action, DMAIC, Design for Manufacturability).
• Proficient in understanding of engineering drawings, documentation, including dimensioning, and tolerance.
• Experience working with project management and interfacing with customers.

• enjoy an autonomous work environment.
• have a LEAN mindset.
• are the first person to help.
• seek out opportunities to bring added value.

• 401K
• Health Benefits:
  
  Medical, Dental, Vision
• Wellness Program
• Life Insurance
• Corporate Sponsored Events
• Skill growth opportunities
• Short Term Disability
• Ability to Advance
• Working with…