Quality Engineer

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.

Essential Functions:

• 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
  
  Skills & Abilities
• 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.

To be considered you’ll need:

• 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.

You will thrive if you:

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

Company Benefits & Perks