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Sr. Quality Engineer
1 week ago
Sr. Quality Engineer (12 month contract // Grand Rapids, MI):
W2 Candidates only. No third party candidates will be considered.
Top Required Skills:
- Experience with Production Quality (CAPA/NCR) and Operational Excellence (Process Characterization and Improvement, Lean/Six Sigma methodologies, and First Time Quality)
- Experience with Capital Expansion/Projects (Process/Equipment Validation and IQ/OQ/PQ)
- Experience with Test Method Development and Validation (Nested vs Crossed, Attribute vs Variable, Design of Experiments)
- Experience with leading and driving small to large projects for capital expediture
Education: Bachelors Degree Required
Experience: 4-6+ years of Medical Device Mftg experience
Duties:
- Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
- Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
- Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
- Adapts machine or equipment design to factory and production conditions.
- May incorporate inspection and test requirements into the production plan.
- Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
- Develops manufacturing processes that are applicable to statistical process control and may be asked to develop those techniques.
- Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
- Ensures processes and procedures are in compliance with regulations.
Required Knowledge and Experience:
- Bachelor's Degree in Engineering, Science, or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science, or technical field with 2+ years of work experience in Engineering and/or Quality
Preferred Skills:
- ASQ certification in Quality Engineering
- Experience with polymer-based products, including extrusion and injection molding ideally
- Familiarity with packaging and sterilization equipment and processes for sterile barrier packaging, including Tyvex and other sealed trays and pouches
- Proven leadership for process and system improvement
- Experience and working knowledge of FDA regulations/ISO standards for medical devices
- Strong interpersonal, organizational and project management skills
- Demonstrated skills in complex decision-making
- Demonstrated ability in coaching/developing team members
- Demonstrated communication skills, both verbal and written
- Strong interpersonal communication and influence skill
- Ability to work in a team-based environment
- Very strong in quality and compliance
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