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Associate Quality Engineer
Under limited supervision, assure the delivery of quality product to customers and assist in maintaining a current and efficient quality management system for Oberg Industries/Oberg Medical by performing the following duties.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
May be responsible for management of inspection department. Including hiring, training, supervision and evaluation of Quality personnel.
Assist in the development and writing of inspection criteria/methods/reports, FMEA studies/reports, FA submittal reports, Gage R&R’s, and PPAP reports as necessary on a customer by customer basis.
Assist in developing and maintaining QMS departmental procedures and other functional elements of the quality management system in accordance with ISO 13485 and CFR Part 820.
Assist in maintaining the documentation system to collect and maintain process and product history and maintain such record keeping in accordance with internal and customer requirements.
Assist in the development, and execution of statistical analysis for product and processes. Work with quality engineering, manufacturing, program management and customers in analyzing the statistical data to support changes in inspection frequency.
Assists with root cause analysis of Customer Concerns and product nonconformities and also in the development/implementation of resultant corrective actions.
Assists in executing process validations (IQ, OQ, PQ) for products and processes.
Adhere to Company quality system requirements, including but not limited to compliance with CFR Part 820 and ISO 13485.
Utilize Key Process Indicator (KPI) information such as NCMR counts, scarp, rework and escapes to propose, lead and execute continuous improvement projects for assigned areas/customers.
Interfaces with customers and suppliers, in person and remotely as required.
Maintain a clean and orderly work area.
Comply with state and federal law safety regulations in addition to Oberg safety and security procedures.
Adhere to company policies and state and federal laws and regulations relating to employment, including promoting a workplace free of discrimination and harassment.
Other related duties as assigned.
PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to sit at a computer terminal and/or stand for extended periods of time. The employee may be required to observe and/or perform some manufacturing/inspection operations. This may involve occasionally working in and traveling through manufacturing areas. The employee must be able to wear personal protective equipment.
WORK ENVIRONMENT: While performing the duties of this job, the employee will regularly have to travel through other departments. The atmosphere is a combination of an office and manufacturing setting.
Must have the ability and interpersonal skills to successfully work as a team member to obtain desired results.
Must be able to understand and apply work-related documents such as operating manuals, maintenance instructions, and procedure manuals.
Must be able to understand and perform to job-related quality standards, methods, usage of inspection devices and reporting as required.
Must be able to travel domestically.
Must be a U.S. citizen or be able to comply with U.S. export regulations.
Must have strong working knowledge of computer programs such as MS Excel, Project, Word, PowerPoint, etc.
Must have a strong working knowledge of statistical analysis and SPC. (Minitab, QC Calc, etc.)
Must have good oral and written communication skills and have a keen attention to detail.
Must possess good organizational and time management skills.
Must be able to organize and prioritize work to succeed in a fast paced and demanding environment.
Must be able to follow instructions and work orders.
Must be able to wear personal protective equipment such as earplugs, safety glasses, and safety shoes.
PREVIOUS EXPERIENCE / EDUCATIONAL QUALIFICATIONS:
Minimum of 2 years’ experience working in an ISO 9000, ISO 13485 or related Quality system environment and/or a two year associates degree.
Experience with First Articles, FMEA and /or PPAP’s is preferred.
Experience with precision measurement equipment, such as drop gauges or surface analyzers, CMM’s, OGP’s is preferred.
The preceding is presented as a matter of occupational information and guidance only, all such other reasonable tasks, duties, and responsibilities as management may deem necessary may be included for satisfactory performance.