Product Quality Engineer II

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30+ days ago Requisition

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 Conformis.

• 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.

• 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/ Conformis is an Equal Opportunity Employer