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Job Title Sr. Supplier Quality Engineer
Job Description In this role, you have the opportunity toto improve sourcing support of our New Product Development (NPD) and Sustaining functions by developing and leading robust sourcing processes that drive selection of the best suppliers based on all technical, quality and business (including cost) requirements throughout the product lifecycle.You are responsible for- Supplier Quality Performance Monitoring, assisting in the development of Quality processes relating to Supplier Quality Control's, working with the team to assist in supplier audits and supplier qualification, assessing supplier capabilities, supplier quality controls, adherence to design outputs, audit and inspection experience, experience with supplier control and design controls, and design ties to supplier.
- CPK, APQP, Process Capability Statistics in relation to Six Sigma which is essentially process optimization, understanding QSIT, serving as a Quality interface to suppliers supporting quality and productivity goals.
- Proactively monitoring and measuring product/process quality and performance trends and troubleshooting of production/release issues.
- Developing and overseeing equipment qualification and process validation plans and lead continuous improvement projects based on process/product trends, customer complaints, industry standards and government regulations.
- Assuring quality systems of OEMs, manufacturers and suppliers are maintained and acceptance criteria are in alignment with component/product use and customer expectations.
- Providing Quality oversight of product/process change requests from suppliers, ensuring appropriate regulatory review and adequate validation to support requested changes.
- Driving supplier improvement via SQIP (Supplier Quality Improvement Plans) and Supplier Owned Quality Assessment (SOQA).
- Serving as internal and supplier quality auditor, managing planning, execution, reporting and closure of audits and audit findings.
- BS, Mechanical Engineering, Biomedical Engineering, Process Engineering or related technical discipline preferred
- Minimum 5+ years professional experience in this or an applicable role
- ASQ Certified Quality Engineer a plus
- Green Belt or Black Belt certification in Six Sigma / Lean Sigma a strong plus
- Supplier Management Engineering position in a medical device (Class II & III) or similar environment desirable, not required
- Knowledge and understanding of the software Windchill & Trackwise.
- Working with cross functional departments in regard to non-conformance investigation and resolutions.
- Proven project management skills in a technical environment
- Ability to lead technical teams including engineering and scientific personnel
- Proficient with geometric tolerance specifications
- Development of Go/No-Go gauges
- Evaluation of measurement system capabilities and biases
- Process qualification and validation
- Non-conforming Materials / MRB participation experience required, leadership of MRB is a plus.
- 3 years specific engineering experience (medical device preferred)
- 3 years experience in application and leading problem-solving, root cause analysis and related Corrective and Preventive Actions (including verification)(CAPA)
- CAPA (Define / Implement / Verify CAPA plans) leadership
- Sound understanding of quality concepts, regulatory compliance requirements and tools including ISO 13485:2003 and the FDA QSR
- Must be able to read blueprints and diagrams.
- Proficient in technical mathematics and statistical process control
- Must be computer proficient (Microsoft Office Suite required). Ms-Project, Mini-Tab or JMP (statistics) and Visio (flowcharting) experience a plus.
- Proven ability to lead (influence) in a cross-departmental technical environment
- ID: #20835224
- State: Colorado Coloradosprings 80901 Coloradosprings USA
- City: Coloradosprings
- Salary: USD TBD TBD
- Job type: Permanent
- Showed: 2021-10-08
- Deadline: 2021-11-08
- Category: Architect/engineer/CAD