Summary
This position will be the lead HMCS Quality presence at the site.
They will be responsible for ensuring the desired customer experience through supporting the process development of product that is manufactured and ensuring conformance to customer specifications and requirements, developing robust statistically based inspection methods, primary support for investigating, evaluating, and disposition of nonconforming product.
They will ensure the Quality systems (ISO 13485) are effectively utilized and compliance to the proper regulations is enforced. This position reports to the Site Quality Manager/Leader.
Resposibilities
The incumbent will:
- 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.
Education:
- Snr Engineer - BA/BS in an Engineering discipline with 5-7 years of Experience, or BA/BS in a scientific discipline with 7-10 yrs in a engineering or technical role.
- Engineer - BA/BS in an Engineering discipline with 2-3 years of Experience, or BA/BS in a scientific discipline with 2-4 yrs in a engineering or technical role.
Experience:
- 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.
