Description
Position Summary: Lead technical efforts to conduct precise dimensional inspections using Quality Dimensional Tools and Techniques. Manage First Articles to completion, utizling the equipment and resources. Reports on the status of inspections and materials. Develops and optimizes programs for use on QC measurement systems. Individual must manage and support technical projects and manage deliverables. In addition, position is responsible to ensure proper documentation according to cGMP's and current procedures. Ensure personnel are properly trained, maintain equipment appropriate and source new equipment/technology. Performs all duties using safety conscious practices. Primary Duties:
- Leads team to develop and optimize programs using CAD models, engineering drawings and dimensional specifications for First Article Inspection and routine QC Measurements.
- Manages precise dimensional inspections using Quality Dimensional Tools and Techniques on Optical Gauging Product (OGP) multi-sensor laser measurement system, Keyence equipment, precision mechanical measuring instruments, Hexagon Coordinate Measuring Machine (CMM), Nikon CMM, optical comparators, microscopes, measure scopes, meters and other various electrical test equipment. to ensure product quality and conformance to specifications.
- Lead and execute complex First Article Inspections, including graphical representations of measurement results.
- Program the CMM Equipment for new and routing parts, utilizing the PC-DMIS CAD++ Software.
- Develop and generate clear and concise inspection reports within the QC measurement systems.
- Work closely with engineers, technicians, and other team members to ensure accurate and timely inspections.
- Drive Continuous Improvements for QC Measurement Systems, including SME for new equipment and software upgrades. Performs Assessment of Validity as needed.
- Participate and Contributes to Functional Requirements, Standard Operating Procedures, GXP Assessments for QC measurement systems.
- Manages the IQ/OQ/PQ of new equipment installation and decommissions QC measurement systems as needed.
- Evaluates new equipment and technology as needed.
- Manages Change Controls to define the start up needs and impact assessment require for QC measurement systems.
- Supports calibration and preventative efforts to maintain QC equipment.
- Analyze inspection data to identify trends, potential issues, and necessary corrective actions.
- Acts a Technical SME for the Incoming QC Measurement Systems, as needed. Provides technical writing as needed.
- Troubleshoot and resolve programming issues for QC measurement systems and performs investigations of out of specification results, including working with vendors/suppliers as necessary to diagnose and remedy the issue.
- Develop training programs for technical QC measurement systems.
- Participate, lead meetings and project timelines and deliverables with cross functional teams.
Knowledge, Experience & Skills:
- Requires a Technical Degree and 7 years of work experience in a technical work setting demonstrating skills in CAD models, GD&T, dimensional tools and techniques; or a Bachelor's Degree (Engineering, Mathematics, Physics or related) and 5 years of work experience in a technical work setting skills in CAD models, GD&T, Dimensional tools and techniques.
- Usage of advanced measuring equipment such as CMM, Fixture Builder Software or similar software program, PC-DMIS software or similar software program.
- Proficiency in precision mechanical measuring instruments and ability to read and interpret complex blueprint drawings will be accepted in lieu of the degree, in addition to other requirements below. having focused competence in the use of Quality Dimensional Tools.
- 2+ years of Management Experience preferred.
- 2+ years of Project Management preferred.
- Excellent written and verbal communication skills to effectively convey technical information.
- Meticulous attention to detail and accuracy.
- Ability to analyze complex problems and develop effective solutions.
- Expert ability to use precision mechanical measuring instruments, coordinate measuring machine, optical comparators, microscopes, measure scopes, meters and other various electrical test equipment.
- Expert ability to read and interpret complex blueprints, and strong knowledge of Geometric Dimensioning & Tolerancing (GD&T).
- Strong interpersonal skills are required to interaction with all levels of the organization. Also requires a solid analytical approach to decision making and problem solving and consistent decision making.
- Requires strong computer skills including CAD and Microsoft Office Package (Excel, Word, etc.).
- Must have an advanced knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO, QSR, UL, CSA, VDE, etc.).
- Ability to work with limited supervision and to manage projects and indirectly manage people in a timely fashion.
- Ability to be a representative in groups of peers from production, engineering, R&D, and quality.
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BioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at (385) 770-1132, by email at [emailprotected], or by dialing 711 for access to Telecommunications Relay Services (TRS).
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