Instant Systems Inc. · 10 hours ago
Quality Engineer
Norfolk, VA
Full-time
Onsite
Mid Level
4+ years expInstant Systems Inc. is seeking a highly motivated and detail-oriented Quality Engineer to join their team. This role is responsible for developing, optimizing, and maintaining manufacturing processes to ensure high-quality production of medical device components, and requires hands-on experience in a manufacturing environment with a strong background in quality systems.
BiotechnologyManufacturingMedical Device
Responsibilities
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
Qualification
Required
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 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
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
Preferred
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
Benefits
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
Company
Instant Systems Inc.
Instant Systems produces single use supplies, packaging and specialized kits for the rapidly advancing biotechnology sector; specifically in the areas of cell-based assay/culturing, tissue engineering/regeneration, biopharmaceuticals and fermentation.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Tara Ramsey
President & CEO
Uzair R.
Chief Operating Officer
Company data provided by crunchbase