Quality Engineer

Join to apply for the Quality Engineer role at Instant Systems Inc.

The role involves developing, optimizing, and maintaining manufacturing processes to ensure high-quality production of single-use supplies, including medical device components, 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.
• Coordinate suppliers and verify quality standards in accordance with industry and customer requirements.
• Develop and implement supplier management programs.
• Identify technical problems and cost reductions with suppliers.
• Manage supplier corrective actions.
• Provide quality support across the product life cycle (design, qualification, testing, release to production, release to customer).
• Conduct quality investigations (CAPA, NCR) and Material Review Board (MRB).
• Coordinate activities between cross‑functional teams for FRACAS.
• Drive root‑cause corrective actions (RCCA) for quality issues.
• Utilize systematic RCCA and Six Sigma methods, tools, and techniques.
• Support third‑party, customer, internal, and external audits.
• Support inspection and ensure compliance of engineering verification, acceptance, and qualification tests.
• Define quality standards, identify CTQ requirements, and apply key process indicators.
• Develop quality assurance plans with cross‑functional teams.
• Authored validation protocols and reports.

• Ability to write reports, business correspondence, and create project plans.
• Ability to effectively present information and respond to questions from customers and management.
• Ability to solve practical problems in situations with limited standardization.

• Bachelor’s degree and minimum 4 years of relevant experience; or graduate degree with minimum 2 years of experience; or in lieu of a degree, minimum 8 years of experience.
• Knowledge of plastic materials is 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, Root Cause/Ca, DMAIC, DFMA).
• Proficiency in interpreting engineering drawings, documentation, dimensioning, and tolerance.
• Experience with project management and interfacing with customers.

• 401K
• Health benefits:
  
  Medical, Dental, Vision
• Wellness program
• Life insurance
• Corporate sponsored events
• Skill growth opportunities
• Short‑term disability
• Ability to advance
• Working with energetic & creative problem solvers
• A mission worthy of your energy and expertise

Applicants for this position must successfully pass background, drug screen, and reference check. The Company reserves the right to adjust, add to, or eliminate any aspect of the above description.