Description:
The Quality Engineer may include direct communications with the customer(s) and making data-driven decisions to ensure quality product is a priority. Leads the development and ensures the integrity of the production and process controls with SPC. Helps troubleshoot and problem solve with data analytics helping collaboration with other functions to pursue issue resolution.
Basic Background Requirements
- FDA or Life Sciences related industry background with + years of experience in medical device, molding and related technology.
- Use Statistical Analysis and Tools.
- Chi Square, ANOVA, DOE, SPC.
- ESD knowledge, GD&T knowledge, MSA knowledge.
- Quality Systems knowledge and International Standards (ISO 13485).
- Experience with Quality Control Plans, PFMEAs and PPAP Requirements.
- CAPA and root cause analysis background.
- Experience writing quality procedures and a having a disciplined problem solving approach.
- Experience in Design transfer processes for new product launches.
- Problem solving techniques and processes.
Important Performance Goals
Short-term: (0 to 3 months)
- Learn KEIND Quality System requirements
- Learn Customer Requirements and Quality flow downs
- Take co-ownership of the customer meetings, data for the meetings, action items
- Learn Quality and Manufacturing documentation and processes
- Learn and provide input to the NCR and NPI process
- Learn and adopt Kimball Electronics philosophies and culture
Midterm: (3 to 6 months)
- Co-own Corrective Actions to closure.
- Reduce overall customer PPM and improve internal yields.
- Implement data-driven actions/poke yokes to improve customer metrics.
- Help investigate customer RMA's and communications of complaints.
- Participate in customer supplier audits.
- Review customer documentation and determine process/flow and equipment/tooling requirements.
- Work with Quality Department to improve the efficiency of inspection methods/processes through improved methods, improved manufacturing processes, and identification of resource needs.
- Train others on quality related requirements, procedures and methods.
Long-Term (6-12 months)
- Implement corrective actions in place to eliminate the failure modes.
- Analyze quality data and identify trends.
- Document implement new processes while improving current processes and documentation.
- Improve your product, processes, yourself and your customer team.
- Guide processes and documentation for NPI production assembly and ECN requirements and maintain revision control of products.
- Ensure products are designed for manufacturability (DFM) and work with Customer to implement DFM recommendations.
- Review customer documentation and determines process/flow and equipment/tooling requirements.
- Use material, equipment and personnel in producing quality products at minimum costs and help develop quotations in response to our customer's RFQs.