Job Summary:
The Product Quality Engineer I 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.
• Assist with the Corrective/Preventive Action (CAPA) program.
• 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 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.
• 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.
• 3 months to 2 years of Quality Assurance/Quality Engineering experience in an FDA regulated environment – preferably QSR (21 CFR Part 820)
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.
restor3d/ Conformis is an Equal Opportunity Employer
Skills Required
- Bachelor of Science degree in Engineering, Science, or Biomedical Science
- 3 months to 2 years of Quality Assurance or Quality Engineering experience in an FDA-regulated environment
- Experience with Quality System Regulation under FDA 21 CFR Part 820
- Excellent written and verbal communication skills
- Strong attention to detail, organization, analytical ability, and time management
- Ability to work independently and collaboratively with minimal supervision
- Solid knowledge of Microsoft Office
What We Do
restor3d enables surgeons to improve the reconstruction and repair of the human body through 3D printed implants with enhanced anatomical fit and superior integrative properties. Leveraging expertise and experience in 3D printing of key biomedical materials spanning a wide range of properties, restor3d seeks to improve medical device solutions.
