Quality Engineer

Company Description

Brunk Industries is a family-owned, globally recognized industry leader specializing in high precision metal components for the medical device industry, as well as other high-tech applications. They offer a competitive salary, a wide range of attractive benefits, a flexible work environment and a culture built on innovation and excellence.

Job Description

Position Summary:

• Under limited supervision, assure the delivery of quality product to customers and assist in maintaining a current and efficient quality management system for Brunk Industries. 

Responsibilities:

• This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities. Employees may perform other related duties as negotiated to meet the ongoing needs of the organization.
  • Responsible for the development and writing of inspection criteria/methods/reports, FMEA studies/reports, FAI 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 ISO9001, AS9100, TS16949, ISO 13485 and 21 CFR Part 820.  
  • 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 for the development and execution of statistical analysis for product and processes. Work with manufacturing, program management and customers in analyzing the statistical data to support changes in inspection frequency.
  • Responsible for root cause analysis of Customer Concerns and product nonconformities and 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 ISO9001, AS9100, TS16949, ISO 13485 and 21 CFR Part 820.   .
  • Interfaces with customers and suppliers, in person and remotely as required. 
  • Maintain a clean and orderly work area.
  • Provide guidance and oversight to technical staff in the deployment and maintenance of a documented calibration system.
  • Compare parts with specified dimensions using appropriate measurement equipment.
  • Make judgment on the inspected part and give approval if part is acceptable.
  • Use PC and automation inspection equipment.
  • Assist in the development and implementation of an effective APQP process during new product development.
  • Work with Corporate Quality Manager to research customer complaints and develop more robust corrective actions and subsequent preventive actions.
  • Establish “In-process Inspection Procedures” when required.
  • Certifies daily release of inspected parts to the customer.
  • Acts as inter-departmental liaison.
  • Assist with Product, Process, Internal and External auditing.

Qualifications

• OGP Flash 500/450/302, Zone 3, and Measuremind software. Mitutoyo CMM machines preferred.
• Proficiency in use and ability to analyze data with the aid of data collection and SPC Software.
• QC Gage, QC Calc, Smart Profile, Smart Fit, Measure link and Geomeasure Software preferred.
• Demonstrate data analysis with Mini-Tab, JMP.
• Operate micrometers, indicators, calipers, height gages, optical comparators, and other inspection tools.
• Knowledge of GMP Regulations, GDP, ISO Requirements, and general understanding of OSHA regulations.
• Must have the ability and interpersonal skills to successfully work as a team member to obtain desired results.
• Must be able to understand and perform to job-related quality standards, methods, usage of inspection devices and reporting as required.
• Must have strong working knowledge of computer programs such as MS Excel, Microsoft AX, Project, Word, PowerPoint, 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.

Education and Experience:

The minimum educational requirements listed below may be substituted by relevant experience, learned competencies and/or certifications obtained throughout one’s career.

• Six Sigma Green Belt certification or a minimum of six years of quality experience
• High School Diploma or GED equivalent required.
• Associate’s or Bachelor’s Degree desired, preferably in Quality Management, Industrial or Mechanical Engineering, or another closely related technical field.
• 8 or more years of related work/industry experience may be considered in lieu of preferred educational requirements.
• ASQ and additional certifications preferred.

Work Environment/Physical Requirements:

• 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. 
• Light lifting (30 lbs. or less).
• Must wear safety glasses and hearing protection while in the manufacturing areas.

Additional Information

All your information will be kept confidential according to EEO guidelines.

info@panarogroup.com