Job Summary

The Quality Engineer 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.

Duties and responsibilities

• Develop and maintain strong internal working relationships across the company.
• 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.
• Performs other related duties as assigned.

Required Skills:

• 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.
• Excellent organizational skills, with the ability to prioritize work.

Education and Experience:

• Bachelor of Science in Engineering, Science, or Biomedical.
• Minimum 3 months to 2 years of experience with a comprehensive knowledge of Medical Device regulations including FDA 21 CFR 820 and other applicable international standards with hands on experience in working within a quality system under regulatory requirements including a background in device design, testing, and FDA clearance.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint).
• Ability to travel as needed (≤ 10% of the time).
• ASQ CQE and CQA Certifications or related quality/regulatory certification a plus.

Physical Requirements:

• Position may involve the use of basic hand tools and inspection and cleaning equipment
• Position may involve handling of or exposure to metallic powders, mill coolant, tapping fluid, and polymeric resins.
• Limited physical requirements other than general skills required to participate in laboratory experiments, production activities, or other similar activities.
• Standard working conditions, including office environment, laboratory, aseptic surgical (when visiting surgical centers and viewing surgeries), and general travel.
• Prolonged periods sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.