Senior Quality Engineer - DIRECT HIRE!

Manpower Engineering is exclusively partnering with an industry leading medical device/plastics company in the Greater Racine, WI Area on a highly visible direct hire/permanent Senior Quality Engineer position.

The company's products save lives, make patients healthy, and keep people safe. They look to hire people who value a positive work culture, want to be part of a winning team, have a desire to learn and grow, and are looking for the opportunity to stretch their current talents and skills to the next level and beyond.

Our client offers a very generous compensation plan, great benefits package, and relocation assistance (if needed).

JOB DESCRIPTION

In this role, you'll be in a highly visible position and provide analysis and systems development to ensure products are manufactured to meet or exceed Customer requirements and expectations. This person will also work to improve quality for the product while identifying and eliminating waste.

Responsibilities:

• Develop and initiate standards and methods for inspection and testing.
• Conduct root cause analysis, analyze failures and implement corrective action for process/product related concerns and customer complaints.
• Interfaces with customer to resolve complaints, corrective actions, engineering changes and validation requirements.
• Develop quality plans from customer specifications to meet customer, company and QMS requirements.
• Perform and analyzes capability studies, Gage R&R, and First Article Inspection Reports on both new and existing products.
• Facilitate improvements to the Quality Management System via updates to procedures and Work Instructions stemming from audit findings and continuous improvement initiatives.
• Work with engineering to coordinate and prepare sample submission packages; updates and maintains process flow diagrams and process control plans.
• Work with Operations on lean and scrap reduction initiatives
• Work with Engineering and Operations to solve in-house quality concerns, reviews of nonconforming product, recommends disposition and corrective action to prevent re occurrence.
• Creates and maintains company quality documentation, such as quality procedures, work instructions and forms.

Qualifications:

• Bachelor's Degree
• 5+ years of experience
• Experience in Quality Assurance in an ISO or FDA registered manufacturing environment
• Medical device/ISO 13485 experience - experience with 21CFR820 preferred
• Must have strong working knowledge of Statistical Process Control methods using intermediate and advanced statistics. Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• New product introduction (NPI experience)
• Lean/Six Sigma experience
  • Six Sigma Green Belt Certification or higher is a plus
• Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) is a plus
• Experience working with customers and across an organization