Summary: Provide qualityengineering support for all released product lines and manufacturing processes.Supports the introduction of new products and Quality Initiatives. Frequent standing, some travel, some lifting.
Essential Job Duties &Responsibilities:
Research & Development:
- Conduct verification/validationstudies (write protocols and perform analysis of results)
- Participate in design reviews andsupport new product development teams
- Determine process capabilitiesfor internal and external suppliers.
- Design tooling and fixtures tosupport in-process test/inspection of products.
- Assure regulatory compliance ofmanufacturing components and processes.
- Support assigned product linesfrom a quality planning perspective
- Develop and update procedures,work instructions, inspection plans, risk analyses and quality plans
- Perform root-cause investigationof internal nonconforming material/customer complaints and participate in CAPAactivity
- Interface with supply base toachieve quality and continuous improvement objectives
- Perform supplier on-siteassessments
- Monitor and participate inimprovement of production parameters (e.g. scrap, capability, cycle time)
- Monitor and participate in improvementof Quality Management System processes
- Perform Internal and SupplierAudits
- Support and enforce QualityManagement System as needed
- Excellent communication skills(verbal and written)
- Moderate to advanced knowledge ofcomputers and software (e.g. Word, Excel)
- Team orientedfacilitator/mentor/worker
- Customer-focused, goal-orientedself-starter
- Ability to train people atmultiple levels of an organization
- Moderate to advanced statisticalprocess control and capability analysis methods
- Advanced knowledge and usage ofinspection and acceptance sampling standards and techniques
- Ability to design, perform andanalyze controlled experiments
- Ability to perform product andprocess failure investigation
- Moderate to advanced knowledge inthe use of measurement tools, their limitations and sources of variation
- Able to perform and analyze GaugeR&R studies
- Skilled in the applications ofSPC, CpK, DOEs, FMA and Taguchi Techniques for quality engineering
- Good Manufacturing Practice (GMP)
- Experienced in DQ (designqualification), IQ (Installation Qualification), OQ (OperationalQualification), and PQ (Performance Qualification) processes & techniques
- Experience with Internal Auditing
- Experience with Suppliercertification and relationship management
- Familiar with reliabilityconcepts and methods
- Familiar with Cost of Qualityconcepts
- Certified Quality Engineer (CQE)and a minimum of 6 years experience in quality field or a minimum of 4 yearsexperience in medical manufacturing
- Associates degree with a minimumof 4 years related experience
- Masters degree with a minimum of1 year related experience
- BS degree in technical disciplinewith 2 years minimum experience
LSISolutions is an equal opportunity employer and does not discriminate on thebasis of any legally protected status or characteristic.