Quality Engineer | Green Bay

Pioneer Metal Finishing is the leading surface engineering company in North America. For over 75 years, we’ve delivered consistent, quality metal finishing solutions for mission-critical applications. Our advanced surface modification technologies and scalable execution improve the performance of mission-critical products and enhance brand value for companies in the healthcare, aerospace, automotive, and industrial markets. We encourage you to learn more about opportunities with Pioneer Metal Finishing and join our team today!

Job Summary

The Quality Engineer assumes primary responsibility managing the quality systems and processes for the division including the preparation, application registration and continued compliance related to ISO certifications. This role, in collaboration with the operational leadership, is responsible for setting up the systems and processes to ensure product specifications and standards are understood, communicated, monitored and produced. The quality engineer collaborates with and supports both Program Management and Operational team members to throughout the product lifecycle. In addition, ownership and involvement with the ISO 9001 Quality Management System / IQMS Quality module and internal audit process is required.

Essential Job Duties/Responsibilities

• Complete comprehensive documentation packages such as PPAP and test data submissions.
• Accurately review and approve quality criteria and finishing requirements of customer materials and material processes.
• Collaborate with teams on quality, risk management, safety, and reliability.
• Collects and reports out on the required data and charts quality goals established by the management team.
• Supports measuring and analyzing key metrics to monitor and improve performance, which includes leading productivity improvements.
• Perform contract and feasibility reviews through the First Article, Sample and Quotation Systems.
• Develop and forward formal customer corrective action reports.
• Participate in customer conference calls and visits when required.
• Respond to requests for assistance from Production, Pricing, and Customer Service.
• Develop, select and enter process programs and correlating work instructions into the computer system.
• Assist in answering sales and customer questions or concerns pertaining to process and finishing requirements.
• Assist in troubleshooting process problems as they relate to product quality.
• Coordinate and participate in processing, testing and disposition of rework material.
• Review documentation and certify outgoing product.
• Collaborate with project teams to devise and implement methods and procedures for inspecting, testing and validating system requirements.
• Coordinate with engineering team(s) to document, and implement part/material qualification plans, including the identification and use of inspection tools.
• Collaborate with project team(s) to assess the impact and determine root cause and corrective actions for products or materials that do not meet required standards and specifications.
• As needed, conduct First Article, in-process, and final inspection.
• Support and champion quality system processes that support products in development and production environments.
• Participate in engineering and risk reviews and make recommendations to enhance the quality and manufacturability of new designs.
• Engages in product development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards.
• Performs other miscellaneous job duties and related functions as needed.
• Develop pathway to Zero Defect.
  
  
  

Experience And Qualifications

• A College Degree in Quality Engineering with a minimum of 5 years Quality Engineering experience, preferably in the medical device or a related industry. An equivalent amount of directly related experience will be considered in lieu of the College Degree.
• Medical Device Quality System Knowledge Including 21 CFR Part 820 (QSR) & ISO 134852016.
• ISO knowledge and training (ISO 90012008/2015 and ISO 134852016).
• Experience leading organizations through the quality journey to develop a culture of quality and attain ISO certifications.
• Experience participating in internal and external audits (e.g., FDA, Notified Body, Supplier) preferred.
• Experience with CAPA, complaint investigation, field action processes and risk management.
• Certified Quality Engineer, Cost of Quality Audit preferred.
• Advanced Metrology skills - Geometric Dimensioning & Tolerancing.
• Strong General Manufacturing Practice and current Good Document Practices 1, 2 & 3 knowledge.
• Blueprint reading / GD&T.
• Well-versed in Quality tools such as Lean manufacturing, TPE, Mistake proofing, Kaizen and 5-S
• PFMEA (Process Failure Mode Effects Analysis) experience
• IQOQPQ (installation Qualification, Operational Qualification, Performance Qualification) knowledge and experience
• APQP (Advanced Product Quality Planning) experience (preferred).
• Good working knowledge of Supplier Quality Engineering competencies.
• Strong knowledge of statistical analysis.
• Individual must have a hands-on approach.
• Strong organizational and time management skills.
• Ability to resolve issues quickly and recommend preventive solutions.
• Negotiation skills, including understanding of escalation paths.
• Strong computer skills; skilled in Excel, Word, PowerPoint, Minitab, Smartsheet.
• Excellent communication and interpersonal skills.
  
  
  

We offer the following benefits to All Employees immediately upon hire

• Next-Day Pay Don’t wait for payday; access your daily pay the next day!
• Quarterly Incentive Program Paid based on hours worked and business results
• Paid company holidays
• Shift Differentials for 2nd and 3rd shift
• Employee Assistance Program
• Wellness Program
• On-the-Job Training and Advancement Opportunities
• Employee Recognition and Rewards Program
• Fun Recognition Events and more!
  
  
  

Full-Time Employees (30 hours per week) may participate in the following benefits

• Medical, dental, and vision insurance (Eligibility begins on the 1stof the month, following your start date)
• Paid Time Off 80 Hours earned in your first year
• Access to Garner Incentive or a Health Savings Account up to $3,000 annually
• 401(k) plan with a company match of up to 2% of bi-weekly contribution
• Flexible Spending Accounts
• Company-paid Life and Accidental Death & Dismemberment insurance
• Tuition reimbursement
• Additional benefits for employee purchase life insurance, critical illness, voluntary accident, and accidental death & dismemberment
• LiveHealth Online, virtual doctor visits