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 is an Equal Opportunity Employer