for Oberg Industries in Sarver, PA USA
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:
- Responsible for the development and writing of inspection criteria/methods/reports, FMEA studies/reports, FA submittal reports, Qualification reports, Gage R&R?s, and PPAP reports as necessary on a customer by customer basis.
- Responsible for developing and maintaining QMS departmental procedures and other functional elements of the quality management system in accordance with ISO9001, AS9100, TS16949, ISO 13485 and 21 CFR Part 820.
- Maybe responsible for management of inspection department. Including hiring, training, supervision and evaluation of Quality personnel.
- Responsible for maintaining the documentation system to collect and maintain process and product history and maintain such record keeping in accordance with internal and customer requirements.
- Responsible as team member with manufacturing to provides input into the manufacturing process development during the contract review phase of the project to ensure the long term processes are reliable and repeatable.
- Responsible as team member for the development and ongoing maintenance of Oberg?s validation master plan.
- Responsible for the development, implementation and maintenance of statistical data for product and processes. Work with manufacturing, program management and customers in analyzing the statistical data and make recommendations to support changes in inspection frequency supported by statistics/process capability.
- Assists with documenting Customer Concerns and product nonconformities and also in the development/implementation of resultant corrective actions.
- Develops/Updates and executes/documents process validations (IQ, OQ, PQ) and technical reports for products and processes.
- Performs supplier audits as necessary.
- Adhere to Company quality system requirements, including but not limited to compliance with ISO 9001, AS9100, TS16949, CFR Part 820 and ISO 13485.
- Provide guidance and oversight to technical staff in the deployment and maintenance of a documented calibration system.
- Use PC and automation inspection equipment
- Assist in the development and implementation of effective APQP process during new product development
- Work with Quality Manager to research customer complaints and develop more robust corrective actions and subsequent preventive actions.
- Assure parts meet quality standards by participating in the inspection process as required.
- Compare parts with specified dimensional and visual criteria using appropriate measurement equipment. Make judgments, as required, on inspected product and give approval if acceptable.
- Establish ?in-process Inspection Procedures? when required.
- Assist with Product, Process, Internal and External auditing.
- Leads determination of disposition of nonconforming product through MRB (Material Review Board) Upward delegation only permitted.
- Assists corporate manager as necessary with maintaining the calibration of measurement equipment and the necessary records.
- 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 and internationally.
- Must be a <st1:country-region w:st="on">U.S.</st1:country-region> citizen or be able to comply with <st1:place w:st="on"><st1:country-region w:st="on">U.S.</st1:country-region></st1:place> export regulations.
- Must have strong working knowledge of computer programs such as MS Excel, Access, 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 5 years? experience working in the Quality field, preferably as a Quality Engineer with either a medical device maker or medical contract manufacturer and/or a four year college degree.
- Experience working in an ISO 9000, ISO9001, AS9100, IS16949, ISO 13485 or related Quality system environment is required.
- Experience with First Articles, FMEA and /or PPAP?s is required.
- Experience with SPC software programs is preferred.
- Experience with precision measurement equipment, such as drop gauges or surface analyzers, CMM?s, OGP?s is preferred.
- Certification as a Quality Engineer is preferred.
- Internal auditing/supplier auditor experience a plus.
- Experience with lean manufacturing, belt certification is a plus.
- 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.
Job Category: Other / Miscellaneous
Location: Sarver, PA USA
Zip Code: 16055
Posted on: 12/02/2019
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