Kromek are having exciting new opportunity for an experienced Quality Engineer who will take responsibility for developing, implementing, and maintaining procedures for compliance to regulatory requirements, internal procedures, inspection & sampling documents. In this role you will be also developing and implementing systems to improve the detection and prevention of quality failures. A successful candidate will have a background/interest in safety that will drive several key initiatives.
Responsibilities and duties
- Process improvements; analyzes nonconforming product/process/material issues. EHS duties include being a member of the safety team and ensuring compliance to OSHA regulations.
- Supports Manufacturing/Ops transfer activities, including equipment and process qualifications/validations. Participates in Quality planning- facilities and products: requirements, documentation and completion (overview/monitoring).
- Ensuring that workflows, processes, and products comply with safety and regulatory regulations.
- Champion for the RMA process and responsible for diagnosis of incoming material.
- Develop / update / and ensure compliance of processes according to ISO 9001:2015 and OSHA
- Investigating and troubleshooting product or production quality issues.
- Developing corrective actions, solutions, and improvements.
- Responsible for vendor quality and audits.
- Perform quality inspections according to written procedures.
- Assist in the development of new inspection and test methods.
- Provide feedback to QA, Operations and NPD on quality issues.
- Assist product development team members in initiating document changes and the new product development process.
- Integral part of project team for manufacturing transfer activities, equipment and cleanroom qualifications.
Essential skills and experience
- Understanding of ISO9001:2015
- Familiarity of OSHA compliance and regulations
- Self-motivated with attention to detail. Neat and organized work habits
- Good written and oral communication skills, ability to clearly convey concepts and present results to others
Desirable skills and experience
- Six Sigma Black Belt Certification or equivalent
- Requires visual acuity (visual ability to resolve fine detail) and manual dexterity (fine hand and finger movements)
- Requires limited supervision for routine processes, can implement changes with detailed instruction
- Must be available for overtime work
- Must be able to lift at least 10lbs frequently; up to 35lbs occasionally, and heavier weights with assistance
- Must be able to wear required safety protective equipment including but not limited to safety shoes and glasses
- May work in a clean room environment and wear clean room attire
- Must be able to work with or around chemicals
- BS in engineering
- 3-5 years of work experience in an engineering environment
Must be US Citizen or permanent resident.
Kromek is an equal opportunity employer. No person is unlawfully excluded from consideration for employment because of race, color, religious creed, national origin, ancestry, sex, age, veteran status, marital status or disabilities.