SUMMARY: Works closely with QA Manager to develop and ensure that all products or services perform at the highest level of quality meeting/exceeding customer expectations.
DUTIES and RESPONSIBILITIES.
Develop and maintain QMS systems; Key role in establishing process controls, Risk Management and Process Improvements; Actively implements appropriate root cause solutions
Performs internal audits
In collaboration with Design & Manufacturing Engineering develop Inspection Test Plan and review
Work with QA manager to develop KPI’s for appropriate systems measuring organizational performance, report on findings and work closely with appropriate managers and staff to address deficiencies and improvement plan
Verify the quality and performance of the products in addition to troubleshooting the rectification of any existing errors or defects
Participate in data collection for Monthly Quality Metrics to foster process improvement in coordination with Manufacturing Engineering and under the guidance of the QA Manager
Participate in process control, risk management and process improvement, qualification/process validation data (Statistical Process Control) captures data with conclusions drawn; projects defined in collaboration with QA Manager to drive improvements
Participate in data collection and analysis leading to corrective action and root cause closure of defects/scrap identified under the guidance of the QA Manager
Participate in cross-functional teams to perform product and component failure analysis and resolution
Participate in the development of new practices for measurement system analysis activities (GR&R’s FMEA) and procedures to promote data collection and in-process inspection in the manufacturing work centers under the guidance of the QA Manager
Provide technical support to QA Inspectors and/or other departmental personnel as required
Promote an awareness of quality goals and processes throughout the operations and creates an environment committed to continuous quality improvement
Participates in special projects and/or testing with Design Engineering
High School or G.E.D. equivalent; Engineering degree preferred
Five (5) years’ experience in an ISO 9001, ISO 13485 or AS9100 manufacturing environment
Training or experience in Quality Assurance management and industry standards for ISO 9001:2008, ISO 13485 or AS9100; RoHS and REACH experience a plus
Experience with SPC (qualification/process validations), FMEA (Risk Management ISO 14971), ISO 9001, ISO13485/Medical GMP’s, CAR/RCA, NCM/MRB, Auditing, Supplier Quality Management; Process Auditing Experience; RoHS and REACH a plus
Must be a strong advocate for the customer and for product quality
Hands-on experience with use of quality tools such as sampling plans, control charts, SPC and quality improvement techniques such as Cause/Effect diagrams, Pareto charts, Histograms and SPC software with “MiniTab” preferred
Hands-on experience with measuring tools, including but not limited to calipers, micrometers, drop gauges and proven experience with common measurement techniques and applications, testing and inspection equipment
Ability to read detailed engineering drawings and schematics
Good ability to troubleshoot and solve problems
Strong mathematical skills including Metric and English, measurement manipulation and computation with fractions
Strong attention to detail, time management, organizational and communication skills
Working knowledge of Microsoft Office Products
LEMO, a privately owned Swiss company, is a global leader in the design and manufacture of precision custom connection solutions since 1946. Providing high-quality push-pull connectors that can be found in a variety of challenging application environments including medical, industrial control, test & measurement, broadcast/audio/video, and telecommunications. LEMO also provides specialty cable and wire, cable assembly services, prototyping and custom designs.
LEMO USA, a subsidiary of LEMO, is located in Sonoma County among the rolling hills of Northern California's wine county, centrally located just 45 minutes north of San Francisco. LEMO USA provides Sales, Marketing, Engineering and Cable Assembly Services at their facilities located in Rohnert Park.
LEMO requires an uncompromising commitment to QUALITY, EXCELLENCE, and INNOVATION. As such, we encourage and invest in each employee to promote responsibility, personal growth, and integrity.