Quality Engineer
The Opportunity: Drive Quality and Customer Success
We seek a dedicated Quality Engineer to drive continuous process quality and ensure superior product reliability in a high-speed manufacturing environment. You will manage core quality functions: Process Control Plans (PCP) and Process Failure Mode and Effects Analysis (PFMEA). Success is measured by reducing Risk Priority Number (RPN), improving First Pass Yield (FPY), and decreasing warranty costs.
Essential Duties and Responsibilities
- Process Planning: Develop, maintain, and manage core quality documentation, including Process Control Plans (PCPs) and PFMEA.
- Problem Solving (CAPA): Drive Corrective and Preventative Action (CAPA) from both internal metrics (FPY) and external feedback (Warranty claims, customer PPM).
- Root Cause & Failure Analysis: Lead and mentor cross-functional teams in rigorous "root cause" analysis and quick-turnaround failure analysis for customer returns.
- Customer & Crisis Management: Serve as the primary Quality liaison, managing all necessary customer interaction, audits, and the decisive resolution of critical quality issues.
- Operational Excellence & NPI: Own the quality assurance portion of APQP/PPAP for new product introductions and serve as the subject matter expert in all Lean Manufacturing initiatives.
Qualifications
Education and Experience
- A Bachelor’s Degree in a relevant Engineering discipline (e.g., Mechanical, Electrical, Industrial) or related field. OR
- A minimum of 5 years of direct experience in a Quality Engineering role within a manufacturing setting, focusing on process quality techniques and structured quality improvement programs.
- Basic technical knowledge in the manufacturing or processing of complex electrical and/or mechanical devices is required.
- MANDATORY EXPERIENCE: Must be experienced with quality systems and customer/supplier relationships within a highly regulated environment like medical or automotive
- ISO-9000 experience is a must.
- Desirable Certifications: Certified Quality Engineer (CQE) or Certified Quality Technician (CQT) highly valued.
Knowledge and Skills
- Analytical & Statistical Mastery: Strong analytical and mathematical skills, including the ability to apply statistical concepts, process control, and capability studies to practical manufacturing problems.
- Leadership & Mentorship: Proven ability to effectively coach, mentor, and lead technical teams, managing multiple concurrent priorities simultaneously.
- Communication & IT: Excellent technical writing skills for procedures and reports. Must be proficient with standard business software (Word, Excel, etc.) and capable of presenting complex findings to diverse audiences.
Physical Demands and Environment
- Requires frequent standing, walking, sitting, and hands-on work with objects.
- Must be able to frequently lift and move up to 25 pounds, and occasionally up to 50 pounds.
- Work environment involves exposure to moving mechanical parts and moderate noise levels.