Sparton is a leading contract design and manufacturing company with a specialization in electronic and electro-mechanical assemblies. Our customers include, Military, Medical, Biotechnology and Aerospace companies that are highly regulated with specialized needs.
Basic Purpose of Position: Assist in the development and implementation of Quality Procedures in compliance with the ISO-13485 and FDA QSR.
Primary or Major Responsibilities:
- Assure compliance to all Internal Policies and Procedures as well as to all External Standards (QSR, CMDR, ISO 13485 and the MDD).
- Experience in risk evaluation techniques, e.g. HHE/HHA, Product Risk Assessment, SFMEA/HHA, DFMEA, PFMEA & fault tree analysis.
- Assist in the creation of verification and validation test plans.
- Failure mode and root cause analysis of incoming and field failures.
- Production process review and auditing.
- Assist in internal and supplier audits.
- Identify opportunities for improvements to the quality system and propose solutions.
- Create quality plans.
- Support the development, maintenance, and auditing of the Quality Management system.
- Assist in development and implementation of applicable processes to meet Customer requirements, including training, problem solving, and review meetings.
- Drive continuous improvement across facility Key Process Indicators.
- Aid in reliability testing.
- Bachelor's degree in Engineering field or area of study deemed acceptable by the hiring team.
- Minimum of 3 to 5 years engineering experience in related manufacturing position.
- Ability to function effectively in a team environment.
- Capacity to facilitate problem solving and risk activities on a cross functional team.
- Effective communication skills driven by attention to detail.
- Strong DFM and NPI skills.
- Excellent analytical skills using Six Sigma and Lean Principles.
- Good working knowledge of quality/reliability engineering statistical techniques.
- Self-motivated and self-managed.
- Ability to handle multiple projects at the same time.
Sparton Corporation is an Equal Opportunity Employer/Veteran/Disabled 41 CFR 60-1.4