Job Description

Job Summary:

The Product Quality Engineer II will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight.

Essential Duties and Responsibilities:

• Develop and maintain strong internal working relationships across restor3d.
• Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals.
• Prioritize and plan work activities; adapt for changing conditions.
• Assist in maintaining the quality system in accordance with applicable regulatory requirements.
• Identify quality system process improvements and implement solutions.
• Lead or assist with the Corrective Action/Preventive Action (CAPA) program.
• Lead or assist with the Customer Complaint system by performing complaint investigations, including root cause analysis.
• Assist with product inspections as needed.
• Perform Internal Quality Audits of the quality system
• Participate in supplier selection and approval process, including leading supplier audits and review of quality data. 
• Perform investigations of non-conformances and drive corrective actions.
• Participate on cross-functional product development teams.
• Participate in product/process validations.
• Perform risk assessments, gathering cross-functional team input.
• Employ statistical techniques and rationale in decision-making activities driven to support non-conformance trending, CAPA effectiveness, part qualification, and process monitoring.
• Establish and trend quality metrics and data.
• Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements.
• Other responsibilities as assigned.

Qualifications:

• Bachelor of Science in Engineering, Science, or Biomedical. 
• 2+ years of Quality Assurance/Quality Engineering experience in the medical device industry and/or experience in an FDA regulated environment is required.
• Knowledge of FDA 21 CFR Part 820 and ISO 13485, preferred.
• ASQ certification (Certified Quality Engineer, Certified Quality Auditor, Certified Biomedical Auditor) a plus.

Skills, Abilities, Competencies Required:

• Excellent written and verbal communication skills.
• Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
• Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness.
• Strong organizational, analytical, and time-management skills.
• Able to self-motivate and work both independently and as part of a team.
• Must have a solid knowledge of Microsoft office.
• Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail.
• Demonstrated proficiency with FDA and ISO standards for Medical Devices.

Restor3d is an Equal Opportunity Employer