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 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.

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/ Conformis is an Equal Opportunity Employer