Senior / Quality Engineer (Manufacturing / Medical Industry / ISO13485) YH39

Responsibilities

• Work with internal/external customers providing inspection, testing, process capability support, Qualifications/Validations, GRR, Minitab analysis, FAI analysis, and inspection plans in a timely manner.

• Review and update work instructions associated with inspection techniques and inspection equipment. Work with Engineering to meet metrology needs.

• Leads the nonconforming material and product processes which includes but is not limited to Disposition, Investigation, CAPA/Corrections and customer communication.

• Key User and lead in ERP (Quality) and EQMS system.

• Maintain and coordinate internal and external audits (ISO 13485).

• Support the quality methodologies for process changes. Support communication and process changes with the customer.

• Provides training to others based on expertise, resume or demonstrated work experience. Uses training tracking system and ensures training requirements are up to date on a regular basis.

• Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, customer returns, corrective actions, and re-validations.

• Enhances department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.

• Any other duties/projects assigned by management & Global Quality Team.

Requirements

• Engineer - BA/BS in an Engineering discipline with min 2 years of Experience, or BA/BS in a scientific discipline with min 3 yrs in a engineering or technical role.

• Experience preferably in an ISO 13485:2003 and/or 9001:2000 work environment.

• Medical device experience a plus.

• ASQ certified Quality engineer preferred.

• Ability to utilize MRP or ERP software and Statistical Analysis Software.

• Root cause analysis training, Project Management, Statistical analysis, SPC, Six Sigma Tools and Geometric Dimensioning and Tolerancing experience.