- Support Quality Engineers with coordinating and implementing projects.
- Install and maintain shop floor workstations and equipment
- Recommend cost effective process procedures.
- Execute test / validation protocols.
- Collaborate with value stream and/or engineering staff to solve technical facilities and quality issues.
- Performs incoming or first article inspection.
- Creates supporting records and reports.
- Understand lot sampling per ANSI/ASQ Z1.4-2008.
- Perform final/sterile release of products, in-process inspections, label inspections and DHR review.
- Participate in cross-functional teams to solve quality issues. Ability to work independently and in a team environment.
- Assist co-workers with coordinate training of quality standards and requirements.
- Communicate inspection information to Operations and quality personnel.
- Assist Quality Engineers with data-gathering activities to support validation and/or studies. Utilize knowledge of quality metrics and statistical metrics i.e. population means process capability and standard deviation.
- Complete basic charts using Microsoft tools. Identify outliers in data using statistical tools.
- Operate advanced measurement systems.
- Coordinate and /or Perform calibration activities.
- A High School Diploma or equivalent is required; a two (2) year Technical Degree is preferred.
- A minimum 2-4 years of experience in a Quality Control regulated industry is required, ASQ Certification preferred 1 plus years of Metrology experience Knowledge of ISO13485/FDA quality systems regulations (preferred)
- Must be detail-oriented and possess effective verbal, written and interpersonal communication skills
- Knowledge of Microsoft Office Mush have working knowledge of quality metrics and statistical metrics, i.e. population mean process capability and standard deviation.
- Must be able to complete basic charts using Microsoft tools and have an understanding of statistical tools and be able to identify outliers in data.
- Must have knowledge and experience to operate the following inspection tools * Caliper * Micrometer * Optical Comparator * CMM * Pin Gages * Microscope Must have the knowledge and experience to operate the following advanced measurement systems * Vision System * SmartScope Intermediate computer skills as required to perform job duties. Ability to perform required duties with minimum supervision