Quality Engineer

Instant Systems Inc.; Norfolk (VA); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

401K

Health Benefits: Medical, Dental, Vision

Wellness Program

Corporate Sponsored Events

Skill growth opportunities

Job summary

Instant Systems Inc. in Norfolk, Virginia is seeking a Quality Engineer to develop and optimize manufacturing processes for high-quality production of medical devices. You will lead investigations, coordinate suppliers, and ensure compliance throughout the product life cycle.

The ideal candidate should have a Bachelor's degree, at least 4 years of relevant experience, and knowledge of ISO quality systems. This position offers competitive benefits including health programs and opportunities for skill growth.

Qualifications

• Bachelor's Degree and minimum 4 years of relevant experience.
• Knowledge of plastic materials is a plus.
• Proficient in ISO Quality Management Systems.

Responsibilities

• Develop and maintain manufacturing processes for quality production.
• Lead quality investigations (CAPA and NCR).
• Coordinate suppliers and verify quality standards.

Skills

Quality tools knowledge

Root cause analysis

Problem-solving techniques

Lean manufacturing

Education

Bachelor's Degree

4+ years of experience

Tools

ISO based Quality Management Systems

Job description

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.

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

• 401K
• Health Benefits: Medical, Dental, Vision
• Wellness ProgramLife 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