- Build and maintain strong relationships with customers.
- Quickly respond to customer requests for assistance, information, and corrective actions.
- Foster effective relationships with suppliers and the Supplier Quality Engineer.
- Manage and coordinate requests for corrective actions as needed.
- Create quality plans for new products using APQP and PPAP methodologies, including FMEAs, Control Plans, MSA, and SPC.
- Collaborate with Engineering, Sales, Purchasing, and Production to resolve quality issues.
- Analyze and address technical and quality system problems for existing products.
- Lead qualification efforts for military-specification and medical products as assigned.
- Ensure all quality assurance equipment is functional and suitable for its intended use.
- Recommend new equipment purchases or upgrades as necessary.
- Develop and update QA documentation to meet customer requirements, internal standards, and quality best practices.
- Prepare or oversee the preparation of first article reports according to AS9102 standards and documented instructions.
- Conduct and document internal quality audits as assigned.
- Assist in the preparation and participation in AS9102, QMS AS9100 & ISO 13485, and Nadcap audits.
- Advise and implement statistical methods in engineering and production, including SPC and experimental design methods.
- Conduct root cause analyses and document corrective actions to satisfy customer requests and enhance the quality system.
- Provide daily guidance to the inspection staff, including work direction and issue resolution.
- Lead technical initiatives across various engineering disciplines, manage project planning, and provide solutions to customer requirements.
- Ensure compliance with ITAR/EAR/EAR99 classifications and communicate customer configurations, ensuring adherence to Departments of State and Commerce regulations.
- Bachelor's Degree in Engineering or Mathematics.
- At least 5 years of experience in industries operating under QMS such as AS9100/ISO 9001/ISO 13485 in an electronic assembly manufacturing environment.
- Familiarity with military, commercial, or medical specifications and experience in ISO 9001/ISO 13485 and Nadcap environments preferred.
- Strong understanding of engineering principles, manufacturing methods, blueprint reading, and inspection equipment.
- Experience with electronic troubleshooting, component trend analysis, and certifications to IPC-610/J-STD-001.
- Proficiency with Microsoft Office, SharePoint, and various database applications.
- Lean/Six Sigma certification is preferred.
- Visual exams confirming 20/20 vision with or without glasses and passing a standard color vision exam pre-hire and every two years.
- Strong teamwork, results orientation, and communication skills.
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Quality Engineer III - Minneapolis, United States - EPM Scientific
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Description
JOB SUMMARY:
A well-established Multi-Industry contract manufacturer has recently shifted the majority of their focus towards the medical device industry. Within the last 18 months, they have gotten the green light to allocate resources towards a growth target of 300% of current med device operations, and are looking to add to their Quality Engineering team.
The Quality Engineer III is responsible for executing comprehensive quality and reliability engineering activities for both systems and products. This role requires expertise in engineering, physical sciences, and quality sciences. The engineer will lead projects and oversee both professional and non-professional staff within a cross-functional team that includes customer service, product engineering, and procurement in an electronic component manufacturing environment.
REPORTS TO:
Quality Engineering Manager
JOB DUTIES:
Customer Liaison:
Supplier Interface:
New Product Introduction:
Existing Products:
QA Equipment and Processes:
Documentation:
Quality Audits:
Statistical Methods:
Corrective and Preventive Action:
Work Guidance:
Technical Leadership:
JOB SPECIFICATIONS:
Education:
Experience:
Skills and Knowledge:
Other Requirements: