Quality Engineer

• Growth Opportunities!|Work on a very unique product
  
  
  

About Our Client

A medical device manufacturer in the Western Suburbs of Chicago is on the lookout for a Quality Assurance Engineer to enhance their expanding Quality team. This company partners with leading OEMs, including Stryker and Medtronic. The role will focus on customer interactions, performing root cause analyses, implementing corrective actions, and driving efficiency initiatives on the production floor. With a rapidly growing presence, this organization is celebrated for its innovative product line that is transforming the medical device landscape.

Job Description

• Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
• Leads and implements various product and process improvement methodologies.
• Review the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
• Leads in the completion and maintenance of risk analysis.
• Leads generation and completion of protocols and reports for test method validations.
• Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.
• Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.
• Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
  
  

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

• Relevant Quality Assurance Engineering Experience
• Bachelor's Degree (Science Related)
• 3+ years of experience in a Cleanroom environment
• Strong Medical Device Manufacturing Experience
• Good knowledge of statistical tool sand appropriate use of Design of Experiments (DOE) when developing recommendations
• Excellent communication and interpersonal skills
• Working knowledge of FDA, EU MDR, ISO 13485:2015, 21 CFR and cGMPs
  
  

What's on Offer

• Competitive base salary between $80,000-$950,000, depending on experience and skills
• Bonus opportunity up to 5%
• Comprehensive benefits package including Medical, Dental and Vision
• Life and AD&D Coverage
• Short-term disability coverage
• 15 PTO Days + 10 holidays
• 401(k) with 6% company match
  
  
  

Contact: Max Sinton

Quote job ref: JN-102024-6561029