WHK Quality Engineer

About the role

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

Responsibilities

• 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 party and third party audits.
• Utilize problem solving techniques such as fishbone diagrams and 5-whys to assist the team in performing 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.
• Auxiliary in the creation, review and approval of procedures, specifications, inspection plans and quality records.
• Communicate quality or compliance concerns with urgency.
• Auxiliary in the processing of rejects and returns by utilizing Epicor ERP.
• Collect data and execute/conduct various analytical/statistical analyses and interpretation as part of process improvements and day-to-day support.
• Auxiliary in the training of personnel.
• Report improvements to management and appropriate cross-functional teams.

Qualifications

• Minimum of a BA/BS is required.
• A minimum of three years’ Quality Engineering experience in the Medical Device is required.
• A minimum of 3 years of GMP experience in an FDA/Health Canada/ISO regulated industry is required.
• Experience with statistical analysis, root cause problem solving, and validations is required.
• Ability to define problems, collect data, establish facts and draw valid conclusions is required.
• Energetic, with strong interpersonal, organizational and communication skills.
• Excellent verbal and written communication skills.
• Demonstrated ability to accomplish work goals.
• Must be able to interpret blueprints in accordance with ANSI Y14.5.
• Must have a strong knowledge of ISO 13485 and other quality systems.
• ASQ certification as a Quality Engineer is preferred.
• Cleanroom experience is preferred.

Requirements

• Safety Training: Complete and maintain General Safety Orientation.
• Qualifications: Minimum of a BA/BS, 3 years Quality Engineering experience in Medical Device, 3 years GMP experience in 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, energetic, with strong interpersonal, organizational and communication skills, excellent verbal and written communication skills, demonstrated ability to accomplish work goals, must be able to interpret blueprints in accordance with ANSI Y14.5, strong knowledge of ISO 13485 and other quality systems, ASQ certification as a Quality Engineer preferred, cleanroom experience preferred.