WHK Quality Engineer

About this position

Salary: $80,000 - $100,000

Summary

The candidate will establish and maintain the quality assurance program to ensure product and quality system compliance with cGMP practices, ISO 13485 requirements and local government and company procedures. The candidate will provide inter‑departmental support by resolving quality issues in a timely manner, creating and maintaining quality documentation, performing validations, participating in audits and facilitating continuous improvement initiatives.

• Provide resolutions to non‑conformances resulting from internal and external processes.
• Perform validations (IQ, OQ, PQ) for WHK infrastructure.
• Perform internal audits and facilitate second‑ and third‑party audits.
• Utilize problem‑solving techniques such as fishbone diagrams and 5‑whys to assist in Root Cause investigations.
• Implement preventive and corrective actions in a timely manner.
• Maintain and review quality metrics and KPIs; perform trend analysis and identify action plans.
• Assist in the creation, review, and approval of procedures, specifications, inspection plans and quality records.
• Communicate quality or compliance concerns with urgency.
• Assist the Quality Manager in processing rejects and returns using Epicor ERP.
• Collect data and execute/conduct various analytical/statistical analyses and interpret results as part of process improvements and day‑to‑day support.
• Assist the Quality Manager in training personnel.
• Report improvements to management and appropriate cross‑functional teams.

• Minimum of a Bachelor’s degree (BA/BS).
• Minimum three years of quality engineering experience in the medical device industry.
• Minimum three years of GMP experience in an FDA/Health Canada/ISO regulated industry.
• Experience with statistical analysis, root‑cause problem solving, and validations.
• Ability to define problems, collect data, establish facts and draw valid conclusions.
• Strong interpersonal, organizational and communication skills; excellent verbal and written communication.
• Experience interpreting blueprints per ANSI Y14.5.
• Strong knowledge of ISO 13485 and other quality systems.
• ASQ certification as a Quality Engineer is preferred.
• Cleanroom experience is preferred.

General Safety Orientation required.

• Language:
  Ability to express thoughts clearly, both verbally and in written context; strong knowledge of Microsoft Office Suite.
• Mathematical:
  Understanding of basic mathematical skills.
• Reasoning:
  Familiarity with processes required to process materials through a manufacturing environment; knowledge to install necessary inspection points.

Employee must regularly talk or hear; frequently stand, walk, use hands; occasionally sit; lift up to 50 pounds; must travel for business; work environment occasionally exposed to moving mechanical parts; noise level moderate.